Uncontrolled systemic disease(s) such as hypertension or diabetes mellitus; blood pressure must be =< the 95th percentile for age, height, and genderXx_NEWLINE_xXPatients with controlled diabetes are allowed on study; controlled diabetes is defined as fasting blood sugar (FBS) = 130 mg/dL or less, and patients whose FBS can be brought in this range with medical therapy are eligible for trial inclusionXx_NEWLINE_xXNo diabetes mellitus currently treated with insulin or sulfonylureasXx_NEWLINE_xXPatients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)Xx_NEWLINE_xXPatients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligibleXx_NEWLINE_xXPatients with known pre-existing diabetes mellitus will be excluded from studyXx_NEWLINE_xXPatients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligibleXx_NEWLINE_xXPatients who have insulin dependent diabetes are not eligibleXx_NEWLINE_xXOther illness that in the opinion of the investigator would exclude the patient from participating in this study, including uncontrolled diabetes mellitus, cardiac diseaseXx_NEWLINE_xXType 1 or 2 diabetes requiring anti-hyperglycemic medication (e.g. metformin, glipizide, insulin)Xx_NEWLINE_xXUncontrolled diabetes as assessed by the investigatorXx_NEWLINE_xXPatients with Diabetes Type I or uncontrolled Type II as judged by the InvestigatorXx_NEWLINE_xXDiabetes mellitus type 1Xx_NEWLINE_xXFasting plasma glucose [fasting is defined as no calorific intake for at least 8 hours]:\r\n* >= 126 mg/dL for those patients without a pre-existing diagnosis of type 2 diabetes mellitus\r\n* >= 167mg/dL for those patients with a pre-existing diagnosis of type 2 diabetes mellitusXx_NEWLINE_xXNon-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment, such as severe hereditary coagulation disorders or insulin-dependent diabetes mellitus that is not optimally controlled with medical management (example, presence of ketoacidosis)Xx_NEWLINE_xXPatients with a history of diabetesXx_NEWLINE_xXPatients may not have a diagnosis of diabetes mellitus as defined by: 1) known diagnosis of diabetes mellitus (DM), or 2) active treatment for DM, or 3) fasting glucose level ? 126 mg/dl, or 4) hemoglobin A1c ? 6.0% obtained within 30 days prior to registrationXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXSubjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrollXx_NEWLINE_xXInsulin dependent diabetes mellitusXx_NEWLINE_xXEvidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosisXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as HbA1c > 7%; NOTE: Subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXImpaired wound healing or other extremity complications due to severe or uncontrolled diabetes mellitus in subjects whose Injectable Lesions are located in an extremity.Xx_NEWLINE_xXParticipants with poorly controlled diabetes defined as a hemoglobin A1c (HgbA1c) >= 7.0%Xx_NEWLINE_xXActive diabetes insipidusXx_NEWLINE_xXUncontrolled diabetes mellitus: hemoglobin A1c (HbA1c) must be < 8% or there must be documentation that control has been good for the week prior to study entry, with daily morning glucoses at < 150 mg/dl; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXFor Part G: Have type 1 diabetes mellitus or a history of gestational diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained with oral therapy as documented by Hemoglobin A1c <7%.Xx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXPatients with serious, uncontrolled, concomitant disorder(s) such as diabetes mellitusXx_NEWLINE_xXPatients with uncontrolled arterial hypertension despite optimal medical management or uncontrolled type I or II diabetes mellitus; patients with well-controlled arterial hypertension or diabetes mellitus are eligibleXx_NEWLINE_xXNo uncontrolled hypertension (>= 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.Xx_NEWLINE_xXPatients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatients with known pre-existing diabetes mellitusXx_NEWLINE_xXType I or type II diabetes, or Hgb A1c > 6.5%Xx_NEWLINE_xXAny other severe, uncontrolled medical condition, including uncontrolled diabetes mellitus (defined as a Hemoglobin A1C ? 9% in subjects with a prior history of diabetes, 28 days prior to study registration) or unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification)Xx_NEWLINE_xXType 1 or Type 2 diabetes mellitus requiring insulin at study entryXx_NEWLINE_xXPoorly controlled diabetes mellitus (defined as HbA1c > 7%). Patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in the study if all other inclusion criteria and none of the other exclusion criteria are met.Xx_NEWLINE_xXSubjects may have diabetes mellitus but must not be taking metforminXx_NEWLINE_xXParticipant has a concurrent diagnosis of type I or type II diabetes that is being treated with insulin or an oral antidiabetic agent; (participants whose type II diabetes is controlled with diet and/or exercise alone are eligible provided they meet all other eligibility criteria)Xx_NEWLINE_xXUncontrolled diabetes or symptomatic hyperglycemiaXx_NEWLINE_xXPatients with diabetes mellitus requiring insulin treatment or uncontrolled steroid-induced diabetes mellitusXx_NEWLINE_xXPatients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligibleXx_NEWLINE_xXEvidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseasesXx_NEWLINE_xXParticipants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone or participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study with approval by the medical monitorXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history or diagnosis of diabetes mellitus who are on therapy and have had good blood sugar control may be included even if the HbA1c is > 8% because this value can take up to 3-4 months to normalizeXx_NEWLINE_xXPatients with insulin-dependent diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXSevere diabetes that is not currently controlled,Xx_NEWLINE_xXUncontrolled diabetes mellitus. Patients with Type II diabetes are eligible if they require only oral hypoglycemic agents and fasting blood glucose level is ?120. Patients with Type I diabetes are eligible if their glycosylated hemoglobin (HbAlc) is ?7.Xx_NEWLINE_xXHave insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.Xx_NEWLINE_xXUncontrolled (per investigator judgment) type I or type II diabetes mellitus.Xx_NEWLINE_xXPatients with uncontrolled type 1 diabetes mellitus. If on a stable insulin regimen may be eligible, after discussion with principal investigator.Xx_NEWLINE_xXSubject has a history of Type 1 Diabetes (T1D) or is considered at high risk for T1D, where high risk is defined asXx_NEWLINE_xXPoorly controlled Type 2 diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are met.Xx_NEWLINE_xXHistory of multiple sclerosis, type 1 diabetes mellitus (DM) or Guillain-Barre syndromeXx_NEWLINE_xXHistory of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months of the first dose of study drug. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) ? 8% or HbA1c > 7 to < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.Xx_NEWLINE_xXPatients with diabetes controlled by diet or medication are allowed on trial; controlled diabetes is defined as FBG < 130 mg/kL in the context of this studyXx_NEWLINE_xXUncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patientXx_NEWLINE_xXPatients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligibleXx_NEWLINE_xXHas a confirmed diagnosis of type 1 diabetes or type 2 diabetes that has been diagnosed by an HbA1c ? 6.5, or is on any hypoglycemic medications (insulin, metformin, etc)Xx_NEWLINE_xXHistory of diabetes and on active diabetes treatment with pharmacotherapy (oral hypoglycemics or insulin)Xx_NEWLINE_xXPoorly controlled diabetes defined by hemoglobin A1C > 9.0 at screening.Xx_NEWLINE_xXUncontrolled hypertension or diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus defined as a Hemoglobin A1C? 7% in patients with a prior history of diabetes, prior to study enrollment.Xx_NEWLINE_xXUncontrolled diseases other than cancer will be excluded. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.Xx_NEWLINE_xXFOR ALL PHASES (Ib AND II): Type I diabetes or patients on insulin therapy are not allowed; uncontrolled type II diabetes not allowed (glycosylated hemoglobin [HbA1c] > 7.5)Xx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXSubjects may have diabetes mellitus but must not be taking metformin or have previously taken metformin within previous yearXx_NEWLINE_xXPresence of poorly controlled diabetes mellitus (glycated hemoglobin [HgbA1c] > 9.0%).Xx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPatients with diabetes are allowed and may be on antidiabetic treatment other than metformin; the diabetes must be under control within normal range (glycosylated hemoglobin measurement [HbA1C] =< 6.5%)Xx_NEWLINE_xXPoorly controlled diabetes mellitus defined as HbA1c > 6.5%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration or gestational diabetes may be enrolled in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXSubjects with uncontrolled type I or II diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin measurement (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXHas poorly controlled diabetes mellitus (HbA1c >7% or random glucose >200mg/dL)Xx_NEWLINE_xXUncontrolled diabetes (defined as Hgb A1C > 8.0%)Xx_NEWLINE_xXPatients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism.Xx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXNot deemed a candidate for concurrent CRT for medical reasons, such as uncontrolled infection (including human immunodeficiency virus [HIV]), or uncontrolled diabetes mellitus which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patientXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXHave poorly controlled diabetes defined as HbA1c values of> 7.5%. Participants with preexisting, well-controlled diabetes are not excluded.Xx_NEWLINE_xXSubject is known to have poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXType 1 diabetes mellitus or type 2 diabetes mellitus actively receiving treatmentXx_NEWLINE_xXInsulin-dependent diabetes; patients with type II diabetes must meet the inclusion criteria outlined aboveXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXSubject has uncontrolled diabetes mellitusXx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXUncontrolled diabetes (fasting serum glucose > 130 mg/dl) despite best medical management or poorly controlled diabetes mellitus defined as hemoglobin (Hb)A1c > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitusXx_NEWLINE_xXSubjects with diabetes.Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8.0% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXCurrently on medication for diabetes or hypercholesterolemiaXx_NEWLINE_xXInsulin-dependent diabetes mellitus (patients with type 2 diabetes controlled with oral glucose lowering agents and the occasional use of insulin are permitted in the study)Xx_NEWLINE_xXSerious medical conditions (congestive heart failure [CHF], angina, diabetes mellitus type 1, chronic obstructive pulmonary disease [COPD], bleeding diathesis)Xx_NEWLINE_xXDONOR: Diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitusXx_NEWLINE_xXInsulin-dependent diabetes mellitus.Xx_NEWLINE_xXUncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.Xx_NEWLINE_xXPersistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease, or human immunodeficiency virus (HIV) infectionXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXDiabetes mellitus.Xx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXHistory of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditionsXx_NEWLINE_xXPart E: Have insulin-dependent (type I) diabetes or a history of gestational diabetesXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitusXx_NEWLINE_xXInsulin-dependent diabetes mellitusXx_NEWLINE_xXPatients are permitted to enroll if they have vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event); however, patients with uncontrolled type I or II diabetes mellitus will be excluded; uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) > 8.5%Xx_NEWLINE_xXPatient has clinically manifest diabetes mellitus for the last 3 months or documented steroid-induced diabetes mellitus.Xx_NEWLINE_xXPatient with poorly controlled diabetes mellitus or documented steroid-induced diabetes mellitus (defined as FPG > 140 mg/dL or Hemoglobin A1C (HbA1C) > 7.8)Xx_NEWLINE_xXPatient with an established diagnosis of diabetes mellitus type I or uncontrolled type IIXx_NEWLINE_xXPatients with uncontrolled type 1 or type 2 diabetes; patients with an elevated risk of hyperglycemia should be excluded from studyXx_NEWLINE_xXPatients with diabetes on metformin; patients with diabetes and not on metformin will be eligible if it is deemed safe after consultation with the patient physician managing diabetesXx_NEWLINE_xXEvidence of current serious uncontrolled concomitant cardiovascular nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal diseaseXx_NEWLINE_xXUncontrolled diabetes mellitus with most recent hemoglobin A1C > 9 performed in last 6 months; this requirement is for subjects with known history of diabetes mellitus onlyXx_NEWLINE_xXDiabetic patients (type I or II diabetes mellitus) must have baseline hemoglobin (Hb)A1c levels NOT higher than 8.5% at study entryXx_NEWLINE_xXFor the Diabetes Expansion Cohort - Subjects with known history of type 2 diabetes\n             mellitus that are well-controlled on a stable dose of oral anti-diabetic agents such\n             as metformin and/or sulfonylureas for 4 weeks prior to screening.Xx_NEWLINE_xXSubjects with documented history of diabetes mellitus except for the Diabetes\n             Expansion CohortXx_NEWLINE_xXFor the Diabetes Expansion Cohort - Subjects who have type 1 diabetes mellitus,\n             maturity onset diabetes of the young, hyperglycemia due to reasons other than type 2\n             diabetes mellitus.Xx_NEWLINE_xXPatients must not have type I or II diabetes that requires anti-hyperglycemic medicationXx_NEWLINE_xXPatients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollmentXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXSubject has clinically manifest diabetes mellitus or documented steroid-induced diabetes mellitusXx_NEWLINE_xXPatients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with FPG > 140 mg/dL or history of documented steroid-induced diabetes mellitusXx_NEWLINE_xXParticipants with poorly controlled diabetes mellitus (defined as hemoglobin A1c [HbA1c] > 7%); subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXPoorly controlled diabetes mellitusXx_NEWLINE_xXSubjects that have been previously diagnosed with type 2 diabetes or steroid-induced diabetes must also meet the additional following criteria:\r\n* Diagnosed with diabetes >= 6 months prior to enrollment\r\n* Hemoglobin A1C (HbA1C) =< 8% at screening visitXx_NEWLINE_xXDiabetes mellitus currently requiring insulin; subjects with a history of steroid-induced hyperglycemia may be enrolled provided that HbA1C at screening visit is =< 8%Xx_NEWLINE_xXHemoglobin A1C (HbA1C) =< 8 if patient has diabetesXx_NEWLINE_xXPatients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trialXx_NEWLINE_xXPatients with clinical manifestation of uncontrolled diabetes mellitus (i.e. treated and/or with clinical signs) or steroid-induced diabetes mellitusXx_NEWLINE_xXNo history of diabetesXx_NEWLINE_xXPoorly-controlled diabetes mellitus (DM)Xx_NEWLINE_xXHistory of autoimmune disease except controlled/treated hypothyroidism, type 1 diabetes mellitus, or certain skin disordersXx_NEWLINE_xXType 1 diabetes or uncontrolled Type 2 diabetesXx_NEWLINE_xXPatient with diabetes mellitus that is suboptimally controlled (fasting plasma glucose >= 140, glycosylated hemoglobin > 7.0) despite oral medication, insulin-dependent diabetes, or documented steroid-induced diabetes mellitusXx_NEWLINE_xXPatients with an established diagnosis of diabetes mellitus type I or not controlled type IIXx_NEWLINE_xXEvidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseasesXx_NEWLINE_xXPatients must not have uncontrolled diabetes mellitus (defined by a hemoglobin [Hgb] A1c > 8) obtained within 14 days prior to registration; optimal glucose control (Hgb A1c =< 8) must be achieved before registration and monitored during protocol treatmentXx_NEWLINE_xXSubjects with uncontrolled type I or type II diabetes mellitus (defined as HgbA1c > 8).Xx_NEWLINE_xXPatients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.Xx_NEWLINE_xXHistory of uncontrolled diabetes mellitus or diabetic neuropathyXx_NEWLINE_xXHave insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c (HbA1c) <7%.Xx_NEWLINE_xXPatients with uncontrolled Diabetes Type I or Type IIXx_NEWLINE_xXSUB-PROTOCOL AIM A: Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HbA1c) > 8% despite adequate therapy; unstable coronary artery disease or myocardial infarction during preceding 6 months; or hypertension uncontrolled by medicationXx_NEWLINE_xXType 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medicationsXx_NEWLINE_xXUncontrolled diabetes: a glycated hemoglobin (Hg A1C) > 7% within 14 days prior to registration; the same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three monthsXx_NEWLINE_xXhistory of Diabetes Mellitus, type 1 or type 2,Xx_NEWLINE_xXSevere and/or uncontrolled medical disease, including: \r\n* Uncontrolled diabetes mellitus (hemoglobin A1c [A1c] > 8) \r\n* Chronic kidney disease stage III or higher (creatinine clearance < 60 mL/min/m^2 by Modified Diet in Renal Disease [MDRD] calculation) \r\n* Active, uncontrolled infectionXx_NEWLINE_xXPatients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligibleXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary.Xx_NEWLINE_xXDiabetic patients with poorly controlled diabetes.Xx_NEWLINE_xXUncontrolled diabetes mellitus.Xx_NEWLINE_xXHave insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.Xx_NEWLINE_xXParticipants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetic agents as documented by hemoglobin A1c (HbA1c) <7%.Xx_NEWLINE_xXDiabetes mellitus uncontrolled by medicationXx_NEWLINE_xXDiabetes mellitus with poor glycemic control (documented hemoglobin A1c > 7% within 4 weeks prior to study entry)Xx_NEWLINE_xXPatients with diabetes are eligible for this trial; all diabetic patients who are enrolled on this study should discuss the need to change their diabetes management regimen with their primary care physician or endocrinologist prior to enrollmentXx_NEWLINE_xXPatients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin measurement (HbA1c) > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXHas a history of autoimmune disorders, including uncontrolled diabetes (\uncontrolled\ defined as Hemoglobin A1c ? 9% in 28 days prior to study).Xx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPatients with type II diabetes currently already on metforminXx_NEWLINE_xXType I or II diabetes mellitus with HbA1c > 8.5% at Screening.Xx_NEWLINE_xXKnown history of autoimmune disease (with the exceptions of medically-controlled hypothyroidism and type I diabetes mellitus)Xx_NEWLINE_xXUncontrolled diabetes mellitus defined as hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus may be included; however, blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c > 8% despite adequate therapy; note: patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c > 7% within 28 days prior to registration despite adequate therapyXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitusXx_NEWLINE_xXPatients with type II diabetes mellitus that is well controlled by dietary measures alone and have a hemoglobin A1c (HgA1c) < 8% are eligible to participate; patients found to have a fasting glucose >= 7 mmol/L (>= 126 mg/dL) or glycosylated hemoglobin > 8% (64 mmol/mol) at screening should be assessed for appropriate management according to local policy; those in whom dietary measures alone provide good diabetic control will be eligible for inclusion; type I or II diabetes mellitus requiring either insulin or oral hypoglycemics for routine management will be excludedXx_NEWLINE_xXPatients with diabetes type I or uncontrolled type II (HbA1c > 8 % assessed locally) as judged by the investigatorXx_NEWLINE_xXDiagnosis of diabetes mellitus; participants with a history of transient glucose intolerance due to corticosteroid administration may be enrolled if all other inclusion/exclusion criteria are met.Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) greater than 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXUncontrolled diabetes mellitus.Xx_NEWLINE_xXPatients with uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXClear contraindication for systemic corticosteroids (diabetes mellitus is not per se a clear contraindication);Xx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXPatients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with FPG >= 140 mg/dL/7.8 mmol/L, or history of documented steroid-induced diabetes mellitus are not eligible for participationXx_NEWLINE_xXPoorly controlled diabetesXx_NEWLINE_xXNot deemed a candidate for concurrent chemoradiation for medical reasons, such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patientXx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXUncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)Xx_NEWLINE_xXDiabetes is not exclusionary provided the patient is not maintained with either oral medications or insulinXx_NEWLINE_xXHistory of type I diabetes mellitus; if a patient has type II diabetes, they must have a hemoglobin (hemoglobin A1C) =< 8%; patients with a screening fasting glucose > 120 mg/dL will be excludedXx_NEWLINE_xXHave poorly controlled diabetesXx_NEWLINE_xXParticipants with fasting blood glucose values that are > institutional ULN; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with regular hemoglobin A1C (HbA1C) =< 8% at screeningXx_NEWLINE_xXDiabetes that is poorly controlledXx_NEWLINE_xXPoorly controlled diabetesXx_NEWLINE_xXDiagnosis of diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes on appropriate therapyXx_NEWLINE_xXPatients with a history of diabetes mellitus (DM) and/or patients who have ever been treated with metformin are not eligible for participationXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus (hemoglobin A1C [HbA1C] > 7.5%)Xx_NEWLINE_xXPatients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose >= 140 mg/dL / 7.8 mmol/L), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus or inadequately controlled hypertensionXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPatients with clinically manifested diabetesXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.Xx_NEWLINE_xXSubjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.Xx_NEWLINE_xXPreviously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilledXx_NEWLINE_xXPatients with brittle diabetes mellitus (DM); brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high; also called \unstable diabetes\ or \labile diabetes\Xx_NEWLINE_xXPoorly controlled diabetes mellitusXx_NEWLINE_xXHistory of Type 1 or Type 2 diabetes requiring regular medicationXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXDiabetes mellitus uncontrolledXx_NEWLINE_xXFor all Arms, patients with poorly controlled diabetes mellitus and/or with clinical signs, and/or steroid-induced diabetes mellitus; for Arm B, patients requiring insulin treatmentXx_NEWLINE_xXHistory of gestational diabetes mellitusXx_NEWLINE_xXPatients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN; note: optimal glycemic control should be achieved before starting trial therapy; at the principal investigator’s discretion, non-eligible patients can be re-screened after adequate medical therapy has been institutedXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXEXPANSION COHORT ONLY: Uncontrolled diabetes mellitus as defined by HbA1c > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatients must not have active or history of clinically significant autoimmune disorders/conditions including type I diabetes; type II diabetes, vitiligo, stable hypothyroidism, and thyroid disease well controlled with thyroid replacement will not be considered exclusion criteriaXx_NEWLINE_xXPatients must not have active or history of clinically significant autoimmune disease, defined as requiring systemic therapy, such as type I diabetes; type II diabetes, vitiligo, stable hypothyroidism, and thyroid disease well controlled with thyroid replacement will not be considered exclusion criteriaXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXDiabetes mellitus uncontrolledXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPart 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ?7%Xx_NEWLINE_xXPatients with abnormal fasting glucose values (> 150 mg/dl) at screening will be excluded; in addition, patients with type 1 diabetes will also be excluded; however, patients with type 2 diabetes will be allowed if diagnosed >= 6 months prior to enrollment, and if presenting with regular hemoglobin A1C (HbA1C) =< 8% at screeningXx_NEWLINE_xXHistory of insulin-dependent or uncontrolled Diabetes MellitusXx_NEWLINE_xXSubjects with diabetes mellitus requiring insulin treatment or subjects with a HbA1C >Xx_NEWLINE_xXPatients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.Xx_NEWLINE_xXDONOR: History of diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin, alpha 1 (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXType I or II diabetes mellitus with HbA1c > 8.5% at screening (modified by amendment 1)Xx_NEWLINE_xXHave insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.Xx_NEWLINE_xXHas poorly controlled diabetes mellitus defined as HbA1c > 6.5%.Xx_NEWLINE_xXDiabetes mellitus requiring insulin treatment or subjects with a hemoglobin A1C (HbA1C) >7%.Xx_NEWLINE_xXPatient has poorly controlled diabetes mellitus (defined as hemoglobin A1C [HgA1c] > ULN), steroid-induced diabetes mellitus or insulin dependent diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatients with uncontrolled diabetes or insulin resistanceXx_NEWLINE_xXDiabetes mellitus currently requiring insulin or insulinotropic therapy or prior history of steroid induced diabetes.Xx_NEWLINE_xXPoorly controlled Type 1 or 2 diabetesXx_NEWLINE_xXPatients with diabetes mellitusXx_NEWLINE_xXPatients with a history of or with a current diagnosis of diabetes mellitusXx_NEWLINE_xXPatients with diabetes requiring insulin or requiring more than one non-insulin hypoglycemia agentsXx_NEWLINE_xXPatients with controlled diabetes are allowed on study; controlled diabetes is defined as fetal bovine serum (FBS) =< 130 mg/dL in the context of this studyXx_NEWLINE_xXHave insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics as documented by hemoglobin A1c <7%.Xx_NEWLINE_xXUncontrolled diabetes mellitus. i. The glycemic targets for subjects with diabetes should take into consideration age, comorbidities, life expectancy, and functional status of the subjects and follow established guidelines (eg, International Diabetes Federation, the European Diabetes Working Party guidelines, and the American Diabetes Association). For younger (< 70 years old) or subjects with life expectancy ? 10 years, the target glycosylated hemoglobin, type A1C (HbA1c) should be < 7.0%. The target HbA1c for older (? 70 years old) subjects or subjects with life expectancy < 10 years should be < 8.0%. Consultation with an endocrinologist is recommended when deciding if diabetes is optimally controlled. c. Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease). d. Active central nervous system involvement as documented by spinal fluid cytology or imaging. e. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. f. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with protocol.Xx_NEWLINE_xXAny patient with known diabetes mellitus currently requiring insulin therapy, or any patient with preexisting diabetes mellitus in poor control, defined as a hemoglobin A1C (HbA1C) value of over 9% within 4 weeks of starting therapyXx_NEWLINE_xXHave poorly controlled diabetes (hemoglobin [HgB] A1C >= 8%)Xx_NEWLINE_xXPatient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitusXx_NEWLINE_xXPatients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, HbA1c > 7%, or FPG > 7.0 mmol/L (125 mg/dL).Xx_NEWLINE_xXType 1 diabetes or uncontrolled Type 2 diabetesXx_NEWLINE_xXType 1 or 2 diabetes requiring antihyperglycemic medicationXx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXDiabetes mellitus that is not controlled with medicationXx_NEWLINE_xXUncontrolled diabetes (HA1C > 10%) despite optional therapyXx_NEWLINE_xXPatients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the InvestigatorXx_NEWLINE_xXUncontrolled diabetesXx_NEWLINE_xXSubject has Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus and currently being treated with insulin or sulfonylureas.Xx_NEWLINE_xXClinically manifest diabetes mellitus, history of gestational diabetes mellitus and/or known glucose intolerance.Xx_NEWLINE_xXDiabetes must be controlled prior to enrollmentXx_NEWLINE_xXPatients with uncontrolled diabetes mellitusXx_NEWLINE_xXDONOR: History of type I or type II diabetes mellitusXx_NEWLINE_xXPatients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ? 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitusXx_NEWLINE_xXThe patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.Xx_NEWLINE_xXSubjects with type 1 or type 2 diabetes mellitusXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycated hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXDiabetes mellitus, unless it is type II diabetes adequately controlled with anti-diabetic agents (A1c < 7)Xx_NEWLINE_xXType 1 or Type 2 diabetesXx_NEWLINE_xXPoorly controlled diabetes (hemoglobin [Hgb] A1C > 9)Xx_NEWLINE_xXUnstable diabetes mellitus.Xx_NEWLINE_xXType I DiabetesXx_NEWLINE_xXPatients with known endocrine disorders including, but not limited to, Cushing's, or Addison's disease; stable diabetes mellitus and hypothyroidism, which have been managed with the same medications at stable doses for the last 6 months are permittedXx_NEWLINE_xXType 1 or 2 diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus or active, steroid-induced diabetes mellitusXx_NEWLINE_xXDiagnosis of diabetes mellitus or current therapy with any drugs used to treat diabetes mellitus, including but not limited to insulin, sulfonylureas, metformin, rosiglitazone (Avandia), and pioglitazone (Actos) within 14 days of study day 1Xx_NEWLINE_xXImpaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremityXx_NEWLINE_xXMust not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic functionXx_NEWLINE_xXHistory of Type I or Type II diabetes mellitus requiring insulinXx_NEWLINE_xXPatients with uncontrolled diabetes (as determined by the investigator); well-controlled diabetic patients with fasting glucose < 150 are eligible if they have been on stable doses of medications for diabetes for at least 4 weeks prior to study entryXx_NEWLINE_xXPatients with diabetes mellitus; (patients with only a history of gestational diabetes will be allowed to be included in the study)Xx_NEWLINE_xXPatients with poorly controlled diabetesXx_NEWLINE_xXType I diabetesXx_NEWLINE_xXType II diabetes requiring chronic therapy with insulinXx_NEWLINE_xXPatient has poorly controlled diabetes mellitus (HbA1c > 8%)Xx_NEWLINE_xXHistory of Type 1 or 2 diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ?160 mg/dL at the prestudy visit. If a diabetic cohort is enrolled, only subjects with a medical history of controlled Type 1 or 2 diabetes mellitus will be enrolled in the cohort.Xx_NEWLINE_xXPoorly controlled diabetes mellitus;Xx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXUncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)Xx_NEWLINE_xXDiabetes is not exclusionary provided the patient is not maintained with either oral medications or insulinXx_NEWLINE_xXUncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)Xx_NEWLINE_xXDiabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulinXx_NEWLINE_xXPatients with uncontrolled diabetes mellitusXx_NEWLINE_xXThe participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.Xx_NEWLINE_xXd. Poorly controlled diabetes mellitus (HbA1C >10.0%);Xx_NEWLINE_xXThe participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their fasting glucose < 160 mg/dL or below the ULN and that they are on a stable dietary or therapeutic regimen for this conditionXx_NEWLINE_xXUncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidismXx_NEWLINE_xXPoorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%; patients with a history of transient glucose intolerance due to corticosteroid administration may be enrolled in this study if all other inclusion/exclusion criteria are metXx_NEWLINE_xXUncontrolled or poorly controlled diabetesXx_NEWLINE_xXFor patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registrationXx_NEWLINE_xXHave uncontrolled diabetes mellitus or uncontrolled hyperglycemiaXx_NEWLINE_xXHemoglobin A1c > 7.5% or diabetes requiring insulin therapyXx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXDiagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.Xx_NEWLINE_xXUncontrolled diabetes at the time of cytoreduction; all patients with diabetes must be optimized on their diabetes regimen prior to initiating pasireotide\r\n* If a patient is diabetic: uncontrolled diabetes as defined by hemoglobin A1c (HbA1c) > 8%* despite adequate therapyXx_NEWLINE_xXType 1 or 2 diabetes requiring anti-hyperglycemic medicationXx_NEWLINE_xXPatients with a known history of type 1 or type 2 diabetes mellitusXx_NEWLINE_xXCurrently has uncontrolled diabetes (at time of screening or enrollment)Xx_NEWLINE_xXType I diabetes or uncontrolled type II diabetesXx_NEWLINE_xXActively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus [DM] with A1c > 8)Xx_NEWLINE_xXDiagnosis of diabetes mellitus type 2Xx_NEWLINE_xXDiabetes mellitusXx_NEWLINE_xXParticipants must have no uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 7%Xx_NEWLINE_xXType 1 or type 2 diabetesXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physicianXx_NEWLINE_xXInsulin dependent diabetes mellitus (DM) and/or metformin useXx_NEWLINE_xXHistory of diabetes mellitus or a neurological disorder that causes distal symmetric polyneuropathyXx_NEWLINE_xXDiagnosis of diabetesXx_NEWLINE_xXPatients with poorly or uncontrolled diabetes in the opinion of the physician(s)Xx_NEWLINE_xXUncontrolled diabetes, untreated hypothyroidismXx_NEWLINE_xXType 1 diabetesXx_NEWLINE_xXHistory of diabetes with retinopathy requiring treatmentXx_NEWLINE_xXDiabetes (defined by being on oral hypoglycemics or insulin)Xx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPatients must not have a history of macular edema, uveitis or diabetes mellitusXx_NEWLINE_xXEndocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitusXx_NEWLINE_xXPatients will also need to satisfy one of the following diabetic criteria: (1) documented diagnosis of piabetes mellitus (diabetes) or pre-diabetes, (2) use of diabetic medication, (3) presence of diabetes risk factors which will prompt diabetic screening of the treating physician’s choice leading to a diagnosis of pre-diabetes or diabetes or the finding of a glycosylated hemoglobin (HbA1c) >= 5.7%Xx_NEWLINE_xXPatient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositisXx_NEWLINE_xXParticipant has known diabetes mellitus - insulin treatedXx_NEWLINE_xXPatients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositisXx_NEWLINE_xXKnown diagnoses of diabetes mellitus, adrenal insufficiency (Addison’s disease), or Cushing’s syndromeXx_NEWLINE_xXUncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physicianXx_NEWLINE_xXPrevious diagnosis of diabetes mellitusXx_NEWLINE_xXUsing medication to treat diabetesXx_NEWLINE_xXtype 1 diabetesXx_NEWLINE_xXMedical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)Xx_NEWLINE_xXPatients with a history of diabetesXx_NEWLINE_xXPoorly controlled diabetes (hemoglobin A1c [Hgb A1C] > 9 or random blood glucose > 250 mg/dL)Xx_NEWLINE_xXSuspected or diagnosed diabetes (with the exception of gestational diabetes);Xx_NEWLINE_xXUncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center’s Glycemic Target Goals is hemoglobin A1C < 7%)Xx_NEWLINE_xXPatients with hemoglobin a1c > 6.3 or who are being actively treated for diabetesXx_NEWLINE_xXHistory of diabetesXx_NEWLINE_xXReported current diagnosis or history of type I diabetes or type 2 diabetes.Xx_NEWLINE_xXUncontrolled medical condition (e.g., uncontrolled insulin dependent diabetes mellitus).Xx_NEWLINE_xXUncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patientXx_NEWLINE_xXDiabetesXx_NEWLINE_xXDiabetesXx_NEWLINE_xXUncontrolled diabetes; subjects with diabetes mellitus are not excluded if the condition is well-controlled (glycated hemoglobin [A1C] < 7.5)Xx_NEWLINE_xXPatients with diabetes mellitus requiring insulin secretagogues and/or insulinXx_NEWLINE_xXMedication-treated diabetesXx_NEWLINE_xXNo history of diabetes mellitus or stroke, or bleeding tendencyXx_NEWLINE_xXHave diabetesXx_NEWLINE_xXDiabetes requiring drug therapyXx_NEWLINE_xXPoorly or uncontrolled diabetes in the opinion of the physician(s)Xx_NEWLINE_xXType I diabetes mellitusXx_NEWLINE_xXPatients with diabetes who are taking insulin or oral agentsXx_NEWLINE_xXDiagnosed with diabetesXx_NEWLINE_xXSubjects may have diabetes mellitusXx_NEWLINE_xXHistory of diabetes mellitusXx_NEWLINE_xXSubjects with a history of diabetes;Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by glycated hemoglobin (HbA1c) > 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessaryXx_NEWLINE_xXPatients with controlled diabetes are allowed on study; controlled diabetes is defined as < 130 ml/dL for the sake of this studyXx_NEWLINE_xXPatients with known diabetes mellitus which is poorly controlled (defined as hemoglobin A1c [HbA1c] > 7%) are ineligible; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion have been metXx_NEWLINE_xXPatients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ? 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.Xx_NEWLINE_xXSubject has uncontrolled diabetes mellitus, in the judgment of the Principal Investigator.Xx_NEWLINE_xXOn treatment with any drug for diabetesXx_NEWLINE_xXCurrently being treated for diabetes or meeting criteria for new diagnosis of diabetesXx_NEWLINE_xXDiabetes being treated with other than diet and lifestyleXx_NEWLINE_xXSerious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)Xx_NEWLINE_xXUncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary;Xx_NEWLINE_xXHave diagnosis of diabetesXx_NEWLINE_xXNo history of diabetesXx_NEWLINE_xXPatients with insulin-dependent diabetesXx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXPatients with uncontrolled diabetesXx_NEWLINE_xXRecent or current history of diabetes mellitus, defined as:1) diabetes therapy within 6 months of enrollment, or 2) fasting blood glucose at “pre-admit” (screening) visit >= 126 mg/dLXx_NEWLINE_xXPoorly controlled diabetesXx_NEWLINE_xXHistory of diabetes mellitusXx_NEWLINE_xXAny patient with diabetes mellitus or steroid-induced hyperglycemia (fasting glucose > 150)Xx_NEWLINE_xXPoorly controlled diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus (fasting blood glucose > 200)Xx_NEWLINE_xXUncontrolled diabetes mellitusXx_NEWLINE_xXHave a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosisXx_NEWLINE_xXHave diabetes mellitusXx_NEWLINE_xXNORMAL VOLUNTEERS: Have diabetes mellitusXx_NEWLINE_xXDiabetes type I or II, or currently on medications to reduce blood sugarXx_NEWLINE_xXHistory of diabetes that is currently being treated without metforminXx_NEWLINE_xXHigh risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)Xx_NEWLINE_xXMajor or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigatorXx_NEWLINE_xXParticipants with known uncontrolled diabetes, defined as a hemoglobin A1C of > 8%Xx_NEWLINE_xXPatients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)Xx_NEWLINE_xXMajor or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigatorXx_NEWLINE_xXrecent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitusXx_NEWLINE_xXPoorly controlled diabetes mellitus (defined as HbA1c > 9%)Xx_NEWLINE_xXSubjects with insulin dependent diabetes mellitus.Xx_NEWLINE_xXPoorly controlled diabetes mellitus defined as hemoglobin A1c (glycosylated hemoglobin; HbA1c) >7%; participants with a history of transient glucose intolerance due to corticosteroid administration may be eligible if all other inclusion/exclusion criteria are met.Xx_NEWLINE_xX