Uncontrolled systemic disease(s) such as hypertension or diabetes mellitus; blood pressure must be =< the 95th percentile for age, height, and gender
Patients 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 inclusion
No diabetes mellitus currently treated with insulin or sulfonylureas
Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
Patients with known pre-existing diabetes mellitus will be excluded from study
Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
Patients who have insulin dependent diabetes are not eligible
Other illness that in the opinion of the investigator would exclude the patient from participating in this study, including uncontrolled diabetes mellitus, cardiac disease
Uncontrolled diabetes as assessed by the investigator
Patients with Diabetes Type I or uncontrolled Type II as judged by the Investigator
Diabetes mellitus type 1
Patients with a history of diabetes
Patients 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 registration
Uncontrolled diabetes mellitus
Uncontrolled diabetes mellitus
Insulin dependent diabetes mellitus
Poorly 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 met
Impaired wound healing or other extremity complications due to severe or uncontrolled diabetes mellitus in subjects whose Injectable Lesions are located in an extremity.
Participants with poorly controlled diabetes defined as a hemoglobin A1c (HgbA1c) >= 7.0%
Active diabetes insipidus
Uncontrolled 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 necessary
Uncontrolled 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 necessary
For 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%.
Uncontrolled diabetes mellitus
Uncontrolled diabetes
Patients with serious, uncontrolled, concomitant disorder(s) such as diabetes mellitus
Patients 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 eligible
No uncontrolled hypertension (>= 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen.
Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
Uncontrolled 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 necessary
Patients with known pre-existing diabetes mellitus
Type I or type II diabetes, or Hgb A1c > 6.5%
Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
Poorly 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.
Participant 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)
Uncontrolled diabetes or symptomatic hyperglycemia
Patients with diabetes mellitus requiring insulin treatment or uncontrolled steroid-induced diabetes mellitus
Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
Evidence 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 diseases
Participants 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 monitor
Uncontrolled 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 normalize
Patients with insulin-dependent diabetes mellitus
Poorly 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 met
Severe diabetes that is not currently controlled,
Uncontrolled 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.
Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
Uncontrolled (per investigator judgment) type I or type II diabetes mellitus.
Patients with uncontrolled type 1 diabetes mellitus. If on a stable insulin regimen may be eligible, after discussion with principal investigator.
Poorly controlled Type 2 diabetes mellitus
Poorly 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.
History of multiple sclerosis, type 1 diabetes mellitus (DM) or Guillain-Barre syndrome
History 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.
Patients 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 study
Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
Has 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)
History of diabetes and on active diabetes treatment with pharmacotherapy (oral hypoglycemics or insulin)
Poorly controlled diabetes defined by hemoglobin A1C > 9.0 at screening.
Uncontrolled hypertension or diabetes mellitus
Uncontrolled diabetes mellitus defined as a Hemoglobin A1C? 7% in patients with a prior history of diabetes, prior to study enrollment.
Uncontrolled diseases other than cancer will be excluded. Subjects with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
FOR 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)
Uncontrolled diabetes mellitus
Presence of poorly controlled diabetes mellitus (glycated hemoglobin [HgbA1c] > 9.0%).
Uncontrolled diabetes
Uncontrolled diabetes mellitus
History of autoimmune disease except for controlled, treated thyroidism or Type 1 diabetes
Patients 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%)
Poorly 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 met
Poorly 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 met
Subjects with uncontrolled type I or II diabetes mellitus
Poorly 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 met
Has poorly controlled diabetes mellitus (HbA1c >7% or random glucose >200mg/dL)
Uncontrolled diabetes (defined as Hgb A1C > 8.0%)
Patients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism.
Poorly 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 met
Uncontrolled 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 necessary
Poorly 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 met
Uncontrolled diabetes mellitus
Have poorly controlled diabetes defined as HbA1c values of> 7.5%. Participants with preexisting, well-controlled diabetes are not excluded.
Subject 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 met
Type 1 diabetes mellitus or type 2 diabetes mellitus actively receiving treatment
Insulin-dependent diabetes; patients with type II diabetes must meet the inclusion criteria outlined above
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 necessary
Subject has uncontrolled diabetes mellitus
Uncontrolled diabetes
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 necessary
Uncontrolled 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 met
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
Subjects with diabetes.
Uncontrolled 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 necessary
Currently on medication for diabetes or hypercholesterolemia
Insulin-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)
DONOR: Diabetes mellitus
Poorly controlled diabetes mellitus
Insulin-dependent diabetes mellitus.
Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.
Patients with vitiligo, alopecia, managed hypothyroidism (on stable replacement doses), psoriasis, resolved childhood asthma/atopy, well-controlled asthma and type I diabetes mellitus are NOT excluded
Persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease, or human immunodeficiency virus (HIV) infection
Diabetes mellitus
Diabetes mellitus.
Uncontrolled diabetes
History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
Part E: Have insulin-dependent (type I) diabetes or a history of gestational diabetes
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
Insulin-dependent diabetes mellitus
Patient has clinically manifest diabetes mellitus for the last 3 months or documented steroid-induced diabetes mellitus.
Patient with poorly controlled diabetes mellitus or documented steroid-induced diabetes mellitus (defined as FPG > 140 mg/dL or Hemoglobin A1C (HbA1C) > 7.8)
Patient with an established diagnosis of diabetes mellitus type I or uncontrolled type II
Patients with uncontrolled type 1 or type 2 diabetes; patients with an elevated risk of hyperglycemia should be excluded from study
Uncontrolled diabetes mellitus with most recent hemoglobin A1C > 9 performed in last 6 months; this requirement is for subjects with known history of diabetes mellitus only
Diabetic patients (type I or II diabetes mellitus) must have baseline hemoglobin (Hb)A1c levels NOT higher than 8.5% at study entry
For 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.
Subjects with documented history of diabetes mellitus except for the Diabetes\n             Expansion Cohort
For 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.
Patients must not have type I or II diabetes that requires anti-hyperglycemic medication
Patients 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 enrollment
Uncontrolled diabetes mellitus
Subject has clinically manifest diabetes mellitus or documented steroid-induced diabetes mellitus
Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with FPG > 140 mg/dL or history of documented steroid-induced diabetes mellitus
Participants 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 met
Poorly controlled diabetes mellitus
Subjects 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 visit
Diabetes mellitus currently requiring insulin; subjects with a history of steroid-induced hyperglycemia may be enrolled provided that HbA1C at screening visit is =< 8%
Hemoglobin A1C (HbA1C) =< 8 if patient has diabetes
Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial
Patients with clinical manifestation of uncontrolled diabetes mellitus (i.e. treated and/or with clinical signs) or steroid-induced diabetes mellitus
No history of diabetes
Poorly-controlled diabetes mellitus (DM)
History of autoimmune disease except controlled/treated hypothyroidism, type 1 diabetes mellitus, or certain skin disorders
Type 1 diabetes or uncontrolled Type 2 diabetes
Patient 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 mellitus
Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
Patients 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 treatment
Subjects with uncontrolled type I or type II diabetes mellitus (defined as HgbA1c > 8).
Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
History of uncontrolled diabetes mellitus or diabetic neuropathy
Have 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%.
Patients with uncontrolled Diabetes Type I or Type II
SUB-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 medication
Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
Uncontrolled 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 months
history of Diabetes Mellitus, type 1 or type 2,
Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
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 anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
Diabetic patients with poorly controlled diabetes.
Uncontrolled diabetes mellitus.
Have insulin-dependent 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 by oral anti-diabetic agents as documented by hemoglobin A1c (HbA1c) <7%.
Diabetes mellitus uncontrolled by medication
Diabetes mellitus with poor glycemic control (documented hemoglobin A1c > 7% within 4 weeks prior to study entry)
Patients 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 enrollment
Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
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 necessary
Poorly 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 met
Uncontrolled diabetes mellitus
Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
Known history of autoimmune disease (with the exceptions of medically-controlled hypothyroidism and type I diabetes mellitus)
Uncontrolled 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 necessary
Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%
Uncontrolled 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 necessary
Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
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 anti-diabetic treatment must be monitored closely throughout the trial and adjusted as necessary
Uncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c > 7% within 28 days prior to registration despite adequate therapy
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
Patients 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 excluded
Patients with diabetes type I or uncontrolled type II (HbA1c > 8 % assessed locally) as judged by the investigator
Diagnosis 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.
Uncontrolled 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 necessary
Uncontrolled diabetes mellitus.
Patients 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 necessary
Diabetes mellitus
Patients 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 participation
Poorly controlled diabetes
Uncontrolled diabetes
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
History 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 excluded
Have poorly controlled diabetes
Participants 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 screening
Diabetes that is poorly controlled
Poorly controlled diabetes
Diagnosis of diabetes mellitus
Uncontrolled diabetes on appropriate therapy
Patients with a history of diabetes mellitus (DM) and/or patients who have ever been treated with metformin are not eligible for participation
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus (hemoglobin A1C [HbA1C] > 7.5%)
Patients 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 mellitus
Uncontrolled diabetes mellitus or inadequately controlled hypertension
Uncontrolled diabetes mellitus
Patients with clinically manifested diabetes
Diabetes mellitus
Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.
Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled
Patients 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\
Poorly controlled diabetes mellitus
History of Type 1 or Type 2 diabetes requiring regular medication
Diabetes mellitus
Diabetes mellitus uncontrolled
For 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 treatment
History of gestational diabetes mellitus
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 necessary
EXPANSION 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 necessary
Patients 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 criteria
Patients 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 criteria
Diabetes mellitus
Diabetes mellitus uncontrolled
Diabetes mellitus
Uncontrolled diabetes mellitus
Part 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ?7%
Patients 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 screening
History of insulin-dependent or uncontrolled Diabetes Mellitus
Subjects with diabetes mellitus requiring insulin treatment or subjects with a HbA1C >
Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.
DONOR: History of diabetes mellitus
Uncontrolled 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 necessary
Type I or II diabetes mellitus with HbA1c > 8.5% at screening (modified by amendment 1)
Have 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.
Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
Diabetes mellitus requiring insulin treatment or subjects with a hemoglobin A1C (HbA1C) >7%.
Patient has poorly controlled diabetes mellitus (defined as hemoglobin A1C [HgA1c] > ULN), steroid-induced diabetes mellitus or insulin dependent diabetes mellitus
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 necessary
Patients with uncontrolled diabetes or insulin resistance
Diabetes mellitus currently requiring insulin or insulinotropic therapy or prior history of steroid induced diabetes.
Poorly controlled Type 1 or 2 diabetes
Patients with diabetes mellitus
Patients with a history of or with a current diagnosis of diabetes mellitus
Patients with controlled diabetes are allowed on study; controlled diabetes is defined as fetal bovine serum (FBS) =< 130 mg/dL in the context of this study
Have 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%.
Uncontrolled 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.
Any 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 therapy
Have poorly controlled diabetes (hemoglobin [HgB] A1C >= 8%)
Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus
Patients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, HbA1c > 7%, or FPG > 7.0 mmol/L (125 mg/dL).
Type 1 diabetes or uncontrolled Type 2 diabetes
History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
Type 1 or 2 diabetes requiring antihyperglycemic medication
Uncontrolled diabetes
Diabetes mellitus that is not controlled with medication
Uncontrolled diabetes (HA1C > 10%) despite optional therapy
Patients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the Investigator
Uncontrolled diabetes
Subject has Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus and currently being treated with insulin or sulfonylureas.
Clinically manifest diabetes mellitus, history of gestational diabetes mellitus and/or known glucose intolerance.
Diabetes must be controlled prior to enrollment
Patients with uncontrolled diabetes mellitus
DONOR: History of type I or type II diabetes mellitus
Patients 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 mellitus
The 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.
Subjects with type 1 or type 2 diabetes mellitus
Uncontrolled 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 necessary
Diabetes mellitus, unless it is type II diabetes adequately controlled with anti-diabetic agents (A1c < 7)
Type 1 or Type 2 diabetes
Poorly controlled diabetes (hemoglobin [Hgb] A1C > 9)
Unstable diabetes mellitus.
Type I Diabetes
Type 1 or 2 diabetes mellitus
Poorly controlled diabetes mellitus or active, steroid-induced diabetes mellitus
Diagnosis 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 1
Impaired wound healing or other extremity complications due to diabetes mellitus in subjects whose Study Lesions are located in an extremity
Must not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic function
History of Type I or Type II diabetes mellitus requiring insulin
Patients 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 entry
Patients with diabetes mellitus; (patients with only a history of gestational diabetes will be allowed to be included in the study)
Patients with poorly controlled diabetes
Type I diabetes
Type II diabetes requiring chronic therapy with insulin
Patient has poorly controlled diabetes mellitus (HbA1c > 8%)
History 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.
Poorly controlled diabetes mellitus;
Diabetes mellitus
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
Diabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulin
Patients with uncontrolled diabetes mellitus
The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
d. Poorly controlled diabetes mellitus (HbA1C >10.0%);
The 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 condition
Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism
Poorly 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
Uncontrolled or poorly controlled diabetes
For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registration
Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia
Hemoglobin A1c > 7.5% or diabetes requiring insulin therapy
Diabetes mellitus
Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin.
Uncontrolled 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 therapy
Type 1 or 2 diabetes requiring anti-hyperglycemic medication
Patients with a known history of type 1 or type 2 diabetes mellitus
Currently has uncontrolled diabetes (at time of screening or enrollment)
Type I diabetes or uncontrolled type II diabetes
Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus [DM] with A1c > 8)
Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
Diagnosis of diabetes mellitus type 2
Diabetes mellitus
Participants must have no uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 7%
Type 1 or type 2 diabetes
Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician
Insulin dependent diabetes mellitus (DM) and/or metformin use
History of diabetes mellitus or a neurological disorder that causes distal symmetric polyneuropathy
Diagnosis of diabetes
Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)
Uncontrolled diabetes, untreated hypothyroidism
Type 1 diabetes
History of diabetes with retinopathy requiring treatment
Diabetes (defined by being on oral hypoglycemics or insulin)
Uncontrolled diabetes mellitus
Patients must not have a history of macular edema, uveitis or diabetes mellitus
Endocrine disorders such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism not controlled with medication, or insulin dependent diabetes mellitus
Patients 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%
Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%
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 necessary
Participant has known diabetes mellitus - insulin treated
Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison’s disease), or Cushing’s syndrome
Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician
Previous diagnosis of diabetes mellitus
Using medication to treat diabetes
type 1 diabetes
Patients with a history of diabetes
Poorly controlled diabetes (hemoglobin A1c [Hgb A1C] > 9 or random blood glucose > 250 mg/dL)
Suspected or diagnosed diabetes (with the exception of gestational diabetes);
Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center’s Glycemic Target Goals is hemoglobin A1C < 7%)
Patients with hemoglobin a1c > 6.3 or who are being actively treated for diabetes
History of diabetes
Reported current diagnosis or history of type I diabetes or type 2 diabetes.
Uncontrolled medical condition (e.g., uncontrolled insulin dependent diabetes mellitus).
Diabetes
Diabetes
Uncontrolled diabetes; subjects with diabetes mellitus are not excluded if the condition is well-controlled (glycated hemoglobin [A1C] < 7.5)
Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
Medication-treated diabetes
No history of diabetes mellitus or stroke, or bleeding tendency
Have diabetes
Diabetes requiring drug therapy
Poorly or uncontrolled diabetes in the opinion of the physician(s)
Type I diabetes mellitus
Patients with diabetes who are taking insulin or oral agents
Diagnosed with diabetes
Subjects may have diabetes mellitus
History of diabetes mellitus
Subjects with a history of diabetes;
Uncontrolled 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 necessary
Patients with controlled diabetes are allowed on study; controlled diabetes is defined as < 130 ml/dL for the sake of this study
Patients 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 met
Patients 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.
Subject has uncontrolled diabetes mellitus, in the judgment of the Principal Investigator.
On treatment with any drug for diabetes
Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes
Diabetes being treated with other than diet and lifestyle
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 necessary;
Have diagnosis of diabetes
No history of diabetes
Patients with insulin-dependent diabetes
Uncontrolled diabetes mellitus
Patients with uncontrolled diabetes
Recent 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/dL
Poorly controlled diabetes
History of diabetes mellitus
Any patient with diabetes mellitus or steroid-induced hyperglycemia (fasting glucose > 150)
Poorly controlled diabetes mellitus
Group III: Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled type II diabetes (glucose levels < 250) may be included
Poorly controlled diabetes mellitus (fasting blood glucose > 200)
Uncontrolled diabetes mellitus
Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis
Have diabetes mellitus
NORMAL VOLUNTEERS: Have diabetes mellitus
Diabetes type I or II, or currently on medications to reduce blood sugar
Participants with known uncontrolled diabetes, defined as a hemoglobin A1C of > 8%
Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)
Poorly controlled diabetes mellitus (defined as HbA1c > 9%)
Subjects with insulin dependent diabetes mellitus.
Poorly 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.