Glycosylated hemoglobin measurement (HbA1c) < 7.0%
Within less than or equal to 14 days prior to registration: Glycosylated hemoglobin (HbA1c) < 7.0%
Glycosylated hemoglobin (HbA1C) >= 8.0%
Glycosylated hemoglobin (HbA1c) =< 7.0%
Subject with poor blood glucose control as per glycosylated hemoglobin > 9%.
Glycosylated hemoglobin (HbA1c) < 7.0%.
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.
Glycosylated hemoglobin (HbA1c) =< 7.9 %
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%)
Glycosylated hemoglobin (HbA1c) =< 7.0%
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
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
Metabolic: glycosylated hemoglobin (HbA1c) < 7.0%
Glycosylated hemoglobin (HbA1c) > 8.5% or fasting plasma glucose > 160 mg/dL at screening
HbA1c > 8.5% at Screening
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
Glycosylated hemoglobin (HbA1c) < 7.0%
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
Patients with HbA1c > 8.5% at Screening
Glycosylated hemoglobin (HbA1c) < 7.0%
Glycosylated hemoglobin (HbA1c) =< 7 % (Gedatolisib can cause hyperglycemia)
Uncontrolled blood-sugar levels defined as HbA1c > 7%
Fasting plasma glucose (FPG) =< 140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) =< 6.4% (both criteria have to be met)\r\n* For patients with FPG >= 100 mg/dL and/or HbA1c >= 5.7% (i.e. threshold for pre-diabetes) at screening, recommend lifestyle changes according to American Diabetes Association (ADA) guidelines, i.e. dietary advice (e.g. small frequent meals, low carbohydrate content, high fiber, balancing carbohydrate intake over the course of the day, three small meals and 2 small snacks rather than one large meal) and exercise; a consultation with a diabetologist is highly recommended
Patients must have a sodium (Na), potassium (K), chlorine (Cl), calcium (Ca), magnesium (Mg), and glycosylated hemoglobin measurement (HbA1c) performed within 7 days prior to sub-study registration
HbA1c of ? 8% (all subjects will have HbA1c test at screening)
Glycosylated hemoglobin (HbA1c) >=7.5 percent (%)
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
HbA1c > 8%.
For all patients (regardless of known diabetes) the following is required at screening: fasting blood glucose =< 135 mg/dL (7.49 mmol/L) and glycosylated hemoglobin (HbA1c) =< 7.0%
Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial (glycosylated hemoglobin [Hba1c] < 7.5)
HbA1c ? 8%
Glycosylated hemoglobin (HbA1c) < 7.0%
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
Glycosylated hemoglobin measurement (HbA1c) < 5.7% within 90 days of enrollment
Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.
HbA1c =< 7.0%
Patients with uncontrolled type II (glycosylated hemoglobin [HbA1c] > 8% assessed locally) as judged by the investigator or abnormal fasting glucose value defined as > 126 mg/dL (> 7 mmol/L)
Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
Hemoglobin (Hb)A1c =< 7.0%
Hgb-A1C ? 7.5%;
Participants with poorly controlled diabetes defined as a hemoglobin A1c (HgbA1c) >= 7.0%
Hgb-A1C =< 7.5%
Hemoglobin A1c < 7%
Glycosylated hemoglobin (Hgb A1c) =< 6.5%
Glycated hemoglobin (Hgb-A1C) level of =< 7.5%.
Abnormal complete blood count, comprehensive metabolic panel, urine, hemoglobin (Hgb) A1c (study physician discretion)
Hemoglobin A1C < 6.5%, within 2 weeks of registration
Poorly controlled diabetes defined by hemoglobin A1C > 9.0 at screening.
Uncontrolled diabetes (defined as Hgb A1C > 8.0%)
Within 14 days of subject registration: Hemoglobin (HB)A1c =< 8%
History of peripheral vascular disease (PVD) that has required surgical or percutaneous intervention or documented PVD that requires medical management with medications such as acetylsalicylic acid (ASA) + clopidogrel; patients with diabetes that is not well controlled are excluded from participation; not well controlled is defined as a hemoglobin (Hgb) A1C of greater than 7.5%
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
Severe 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 infection
Diabetes mellitus with poor glycemic control (documented hemoglobin A1c > 7% within 4 weeks prior to study entry)
Hemoglobin A1c =< 9%
Glycosylated hemoglobin (Hgb A1C) > 8.0%
Has a history of autoimmune disorders, including uncontrolled diabetes (\uncontrolled\ defined as Hemoglobin A1c ? 9% in 28 days prior to study).
Uncontrolled diabetes mellitus as defined by hemoglobin (Hb)A1c > 7% within 28 days prior to registration despite adequate therapy
Hemoglobin (Hgb) A1C =< 8%
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
Obtained within 2 weeks from study entry: Hemoglobin A1c (HgBA1c) =< 8%
Have poorly controlled diabetes (hemoglobin [HgB] A1C >= 8%)
Poorly controlled diabetes (hemoglobin [Hgb] A1C > 9)
Hemoglobin (Hgb) A1C =< 8%
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
Hemoglobin (Hgb) A1C =< 8%
Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%)
Patient received previous treatment with oral AC480
For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registration
Hemoglobin A1c > 7.5% or diabetes requiring insulin therapy
Participants must have no uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 7%
Subjects who have diabetes with a hemoglobin (Hgb) A1c > 7
Glycosylated hemoglobin (Hb A1c) =< 7%
Poorly controlled diabetes (hemoglobin A1c [Hgb A1C] > 9 or random blood glucose > 250 mg/dL)
Patients with hemoglobin a1c > 6.3 or who are being actively treated for diabetes
Hemoglobin A1C > 8.5%
Participants with known uncontrolled diabetes, defined as a hemoglobin A1C of > 8%
Random or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age
Glucose < 200 mg/dl
Uncontrolled diabetes (if non-fasting blood sugar > 200 mg/dl, perform a fasting blood sugar which must be =< 200 mg/dl)
Fasting serum glucose =< 130 mg/dL
Within less than or equal to 14 days prior to registration: Fasting serum glucose =< 130 mg/dL
Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
Patients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
Fasting serum glucose (=< 130 mg/dL)
Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting (no food or drink other than water for 8 hours) blood glucose can be obtained and must be within the upper limits for age
Uncontrolled diabetes as defined by fasting serum glucose > 1.5x ULN
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication.
Normal blood glucose for age
Glucose, serum < 200 mg/dL
Diagnosis of diabetes mellitus defined as\r\n* Fasting blood glucose > 126 mg/dl or\r\n* Random blood glucose > 200 mg/dl\r\n* Hemoglobin A1C > 6.5%
Patients with uncontrolled diabetes or fasting blood glucose > 200 mg/dL may enroll but will not be evaluable for PET imaging
Fasting serum glucose (=< 130 mg/dL)
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients’ primary physicians
Diabetes must be controlled prior to PET-CT scanning (blood glucose < 200 mg/dL)
Fasting glucose within normal limits
Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN
Fasting serum glucose =< 130 mg/dL.
Fasting blood glucose (FBG) < 130 mg/dL
Fasting or random blood glucose within the upper limits of normal for age
If random blood glucose is above upper limits for age, a fasting blood glucose can be obtained and must be within normal limits for age
Blood glucose <1.5 ULN within 30 days of enrollment to study
Fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose =< 130 mg/dL
Fasting glucose =< 160 mg/dL (CTCAE grade 1 baseline)
History of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents) or fasting glucose ? 160 mg/dL at the Pre-Study visit
Fasting serum glucose (=<130 mg/dL)
Metabolic: fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose (=< 130 mg/dL)
Fasting serum glucose =< 130 mg/dL
History of Type 1 or 2 diabetes mellitus requiring regular medication (other than oral hypoglycemic agents including metformin) or fasting glucose ? 160 mg/dL
Glucose >= 80 mg/dL
Fasting serum glucose =< 130 mg/dL
Within 30 days of first vaccination: Blood glucose < 1.5 ULN
Subjects unable to maintain blood glucose less than 200 mg/dl may not be suitable for the PET/MRI substudy
Glucose < 200 mg/dL
Uncontrolled diabetes mellitus, or subjects with either of the following:\r\n* Fasting blood glucose (FBG defined as fasting for at least 8 hours) >= 200 mg/dL (7.0 mmol/L), or\r\n* Glycosylated hemoglobin measurement (HbA1c) >= 8%
Within 4 weeks of preregistration: Blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting
ELIGIBILITY CRITERIA FOR REGISTRATION: blood glucose =< 126 mg/dL fasting or =< 140 mg/dL nonfasting (within one week of registration if patient postop, otherwise within two weeks of registration)
EXCLUSION CRITERIA FOR REGISTRATION: subjects with known diabetes, fasting glucose over 126 mg/dL or random glucose over 140 mg/dL and those taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason; either fasting OR random glucose may be used to determine eligibility
Fasting blood sugar =< 160 mg/dL; patient may be on diabetic medication to achieve glucose control\r\n* Documented fasting blood sugars =< 160 mg/dL\r\n* Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations =< 160 mg/dL may be considered regardless of hemoglobin A1C (HgbA1c) value, if per investigator discretion the subject is considered to have adequate glycemic function
TREATMENT: Patients who have poorly controlled diabetes (defined as fasting blood glucose of > 160 mg/dL (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) and glycated hemoglobin (HgA1c) > 8% are ineligible to receive treatment with everolimus on study; patients with fasting blood glucose > 160 mg/dL may be eligible if the HgA1c < 8%, per PI discretion
Patients with uncontrolled diabetes mellitus (fasting blood glucose controlled by medication, =< 200 mg/dL allowed)
Uncontrolled diabetes (if random blood sugar > 200 mg/dL, perform fasting blood sugar to ensure < 200 mg/dL)
Fasting glucose < 125 mg/dL obtained within 28 days prior to sub-study registration
Fasting glucose < 125 mg/dL obtained within 28 days prior to Step 2 re-registration
Fasting glucose =< 120 mg/dL
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
Fasting blood glucose =< 125 mg/dL within 14 days prior to registration
Fasting glucose < 160 mg/dL
Baseline fasting blood glucose must be =< 140 mg/dL and hemoglobin A1c less than 7.5% (with or without the use of anti-diabetic medications)
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Normal fasting glucose
Diabetes or elevated fasting blood sugar either by history or by hemoglobin A1c (HgbA1c) greater than 6.5% or fasting serum glucose greater than 100 mg/dL on screening labs; if fasting serum glucose is greater than 100mg/dL on screening labs, this test will be repeated to confirm the results
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
Fasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake
Fasting glucose value ? 160 mg/dL (CTCAE Grade 1 baseline)
Patients must not have uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 x ULN) obtained within 28 days prior to registration; optimal glucose control must be achieved before registration and monitored during protocol treatment
Uncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dL
Glucose =< 2 x ULN
Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 milligrams per deciliter (mg/dL)
Random or fasting blood glucose within the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then a follow-up fasting blood glucose can be obtained and must be within the upper normal limits for age
Fasting serum glucose =< 130 mg/dL
Fasting glucose < 140 mg/dL
Type I diabetes mellitus (DM), type II DM patients requiring insulin for chronic blood glucose control, and any patients with a fasting blood glucose > 140 mg/dL (7.8 mmol/L) at screening will be excluded
Fasting glucose < 120 mg/dL
Patients with a fasting blood glucose >= 120 mg/dL (6.7 mmol/L); 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
Fasting glucose < 250 mg/dL; patients with diabetes are allowed to participate, provided that their blood glucose is < 250 mg/dL upon enrollment
Fasting blood glucose within institutional normal limits
Additional criteria for Group B participants who will receive upfront window therapy (does not apply to participants who opt out of window therapy):\r\n* Cytochrome P450 3A4 (CYP3A4) active agents: must not be taking any of the following potent CYP3A4 inducers or inhibitors within 1 week prior to study entry: azole antifungals (such as fluconazole, voriconazole, itraconazole, ketoconazole), rifampin, phenytoin, phenobarbital, carbamazepine, grapefruit juice and St. John’s wort\r\n* Must have measurable disease\r\n* Must not have received emergent radiation therapy\r\n* Serum triglyceride level =< 300 mg/dL and serum cholesterol =< 300 mg/dL\r\n* Random or fasting glucose within the upper limits of normal for age; if random glucose is elevated, fasting glucose must be within normal range
Uncontrolled diabetes, as defined by fasting serum glucose > 1.5 times ULN*
Fasting plasma glucose < 140 mg/dl (may be on antiglycemic agents other than insulin); fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake
Uncontrolled diabetes (as defined by fasting glucose >= 140 mg/dL) and/or insulin-dependent diabetes; fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake; patients currently requiring the use of antiglycemic agents (other than insulin) may be enrolled if fasting glucose < 140 mg/dL
Have a random glucose of =< 65 or >= 200
Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.
Patients with diabetes, OR fasting blood glucose level >= 126 mg/dl\r\n* NOTE: patients with drug induced diabetes are eligible if the offending drug has been stopped and the patient’s fasting blood glucose level has recovered to < 126 mg/dl
Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
f. Poorly controlled diabetes (fasting blood glucose > 180 mg/dL)
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication
Fasting serum glucose =< 150 mg/dl (fasting is defined as at least 8 hours without oral intake)
Patient does not have uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)
Fasting serum glucose =< 130 mg/dL
Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL)
Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)
Fasting serum glucose < 1.5 x ULN obtained =< 7 days prior to registration
Poorly controlled diabetes as defined by a fasting serum glucose > 2.0 x ULN.
Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
Fasting glucose =< 150 mg/dL
The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.
Current diagnosis of type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, or HbA1c 7%
Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN
The participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)? 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not required
Fasting serum glucose (=< 130 mg/dL)
Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: In case this threshold is exceeded, these participants can only be included after initiation or adjustment of glucose-lowering medication.
Free from history of chronic disease including uncontrolled diabetes (fasting blood glucose > 125 mg/dL), hypertension (blood pressure > 130/90 mmHg) or thyroid disease (< 0.4 or > 4.0 mIU/L); this will be determined by review of medical records and/or physician clearance
Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
NON-CANCER PATIENT GROUP: Metabolically unhealthy: abdominal obesity + (at least one of the following: resting blood pressure above 140 systolic or 90 diastolic or anti-hypertensive medication use or fasting glucose above 100 mg/dL or type II diabetes mellitus)
Patients who require frequent (several times a day) monitoring of their blood glucose or patients who have recently been hospitalized for glucose control
Uncontrolled hyperglycemia as defined by any blood glucose of > 300 mg/dl in the past two weeks
Random glucose < 160 mg/dL or fasting glucose < 126 mg/dL (other values require workup to rule out undiagnosed diabetes that may require treatment)
Currently on medications for diabetes treatment (patients with hyperglycemia [random glucose < 160 mg/dL or fasting glucose < 126 mg/dl] but who are not on any drug treatment are eligible)
Patients with fasting capillary blood glucose of > 140 on the day of surgery
Fasting blood glucose =< 120 mg/dL
Fasting blood glucose =< 115 mg/dL
It is recommended glucose be drawn fasting >= 8 hrs; glucose < 126 (diabetics 40–75 years of age are not eligible), within 30 days prior to enrollment\r\n* If glucose is >= 126 the glucose should be repeated fasting to determine eligibility
Fasting serum glucose =< 130 MG/DL
Not frankly diabetic, as measured by a fasting blood glucose =< 126 mg/dL
Type I or II diabetes; documented fasting plasma glucose > 125 mg/dL, current exposure to antidiabetic medications, including insulin
Glucose within 2 x ULN
Blood glucose > 200
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
Uncontrolled diabetes or blood glucose > 175 mg/dl on the day of the FDG-PET scan
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
Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)
Severe diabetes (fasting blood glucose > 200 mg/dl)
Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL)
Any patient with diabetes mellitus or steroid-induced hyperglycemia (fasting glucose > 150)
Uncontrolled diabetes mellitus (fasting glucose > 200 mg/dL)
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
Patient with poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL; optimally participants will have glucose < 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Poorly controlled diabetes mellitus (fasting blood glucose > 200)
Blood glucose >= 200 mg/dL at the time of PET-MRI (or if diabetic, uncontrolled blood glucose); at the discretion of the principal investigator (PI) and the authorized user and with their approval prior to FDG injection, patients with blood glucose >= 200 mg/dL may participate in the study
Patient must not be an uncontrolled diabetic with a glucose of >= 200 mg/dl at the time of PET imaging
Uncontrolled hyperglycemia (defined as inability to achieve a glucose of < 250 mg/dL at time of FDG injection)
Blood glucose of < 80 mg/dL or > 150 mg/dL
Uncontrolled diabetes with a fasting glucose >= 200 mg/dl at the time of PET/MRI imaging
Serum glucose > 200 mg/dL
Fasting glucose > 200 mg/dL or
No diabetes mellitus currently treated with insulin or sulfonylureas
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
Insulin dependent diabetes mellitus
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%.
Patients with known pre-existing diabetes mellitus
Patients with diabetes mellitus requiring insulin treatment or uncontrolled steroid-induced diabetes mellitus
Patients with insulin-dependent diabetes mellitus
Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
Poorly controlled Type 2 diabetes mellitus
Presence of poorly controlled diabetes mellitus (glycated hemoglobin [HgbA1c] > 9.0%).
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
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.
Diabetes mellitus
Diabetes mellitus.
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)
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
Subjects with documented history of diabetes mellitus except for the Diabetes\n             Expansion Cohort
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
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
Poorly controlled diabetes mellitus
Diabetes mellitus currently requiring insulin; subjects with a history of steroid-induced hyperglycemia may be enrolled provided that HbA1C at screening visit is =< 8%
Patients with clinical manifestation of uncontrolled diabetes mellitus (i.e. treated and/or with clinical signs) or steroid-induced diabetes mellitus
Poorly-controlled diabetes mellitus (DM)
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
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 diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%
Patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
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
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
Diabetes mellitus
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
Diabetes mellitus
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
Diabetes mellitus
Diabetes mellitus
History of insulin-dependent or uncontrolled Diabetes Mellitus
Subjects with diabetes mellitus requiring insulin treatment or subjects with a HbA1C >
DONOR: History of diabetes mellitus
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%.
Patient has poorly controlled diabetes mellitus (defined as hemoglobin A1C [HgA1c] > ULN), steroid-induced diabetes mellitus or insulin dependent diabetes mellitus
Diabetes mellitus currently requiring insulin or insulinotropic therapy or prior history of steroid induced diabetes.
Patients with diabetes mellitus
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%.
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
Patients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, HbA1c > 7%, or FPG > 7.0 mmol/L (125 mg/dL).
Diabetes mellitus that is not controlled with medication
Clinically manifest diabetes mellitus, history of gestational diabetes mellitus and/or known glucose intolerance.
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
Unstable diabetes mellitus.
Poorly controlled diabetes mellitus or active, steroid-induced diabetes mellitus
Must not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic function
Patients with diabetes mellitus; (patients with only a history of gestational diabetes will be allowed to be included in the study)
Patient has poorly controlled diabetes mellitus (HbA1c > 8%)
Poorly controlled diabetes mellitus;
Diabetes mellitus
Diabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulin
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
Diabetes mellitus
Actively uncontrolled diabetes mellitus (documentation of history of diabetes mellitus [DM] with A1c > 8)
Diabetes mellitus
Insulin dependent diabetes mellitus (DM) and/or metformin use
History of diabetes mellitus or a neurological disorder that causes distal symmetric polyneuropathy
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
Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin > 8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of > 8%
Participant has known diabetes mellitus - insulin treated
Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
No history of diabetes mellitus or stroke, or bleeding tendency
Subjects may have diabetes mellitus
History of diabetes mellitus
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.
History of diabetes mellitus
Poorly controlled diabetes mellitus
Have diabetes mellitus
NORMAL VOLUNTEERS: Have diabetes mellitus
Poorly controlled diabetes mellitus (defined as HbA1c > 9%)
Subjects with insulin dependent diabetes mellitus.
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
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
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
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 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 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
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.
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 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
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
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 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
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
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
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
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 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
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 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
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;
Haemoglobin <90 g/L
Haemoglobin >= 9.0 g/dL
Hematology: Haemoglobin ? 9.0 g/dl; ANC ? 1.5 × 109/L; Platelet count ? 100 × 109/L
Acceptable haematological function defined as (Patients can be transfused to meet the haemoglobin entry criteria):
Haemoglobin ?9 g/dL
Haemoglobin <90 g/L (<9 g/dL)
Haemoglobin ?9 g/dL;
Haemoglobin ? 9 g/dL
Haemoglobin >=9 g/dL.
Haemoglobin ?9 g/dL
Haemoglobin (Hb) <100 g/L
Haemoglobin ? 8.0 g/dL (may have been transfused)
Haemoglobin 9.0 g/dL
Glycated haemoglobin (HbA1c) < 8%
Fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) < 7%
Glycated hemoglobin (HbA1c) < 6.4%, within 14 days of registration
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
Poorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or glycated hemoglobin (A1C) over 7.5%.
Glycated hemoglobin (Hb A1c) =< 5.7%, or 5.8-6.5% with a normal fasting glucose
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.
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
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
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.
Hemoglobin A1C (HbA1C) < 7.0%
Have a baseline glycated hemoglobin (HbA1c) ? 6.4
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
Has poorly controlled diabetes mellitus (HbA1c >7% or random glucose >200mg/dL)
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
Metabolic - Glycated hemoglobin (HbA1c) ? 8%
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
Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study registration
Hemoglobin A1c (HbA1c) =< 8%
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
Hemoglobin A1C (HbA1C) =< 8 if patient has diabetes
Patients with abnormal fasting glucose values at screening will be excluded (fasting glucose >= 160); 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 hemoglobin A1C (HbA1C) =< 8% at screening
Patient has uncontrolled diabetes, defined as a fasting serum glucose > 150 mg/dl or glycosylated hemoglobin (hemoglobin A1c [HbA1c]) > 7% at screening
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
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%.
Patients with uncontrolled type II (hemoglobin A1C [HbA1c] > 8% assessed locally) as judged by the investigator or abnormal fasting glucose value defined as > 126 mg/dL (> 7 mmol/L)
Hemoglobin A1c (HbA1c) =< 8 %
Diabetes mellitus on active treatment, or subjects with either of the following:\r\n* Fasting blood glucose (FBG) >= 126 mg/dL (7.0 mmol/L), or \r\n* Hemoglobin A1C (HbA1c) >= 6.5%
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
History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ?6.5%
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
Diabetes mellitus requiring insulin treatment or subjects with a hemoglobin A1C (HbA1C) >7%.
Patient with diabetes mellitus: fasting glucose =< 120 mg/dL and hemoglobin A1c (HbA1c) =< 8%
Hemoglobin A1C (HBA1C) < 7.0%
Patients with abnormal fasting glucose values (values > upper limit of normal [ULN] or < LLN) 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 a normal fasting glucose value and a regular hemoglobin A1C (HbA1C) =< 8% at screening
Subjects with fasting glucose >125 mg/dL in 2 independent measurements or glycated hemoglobin (HbA1c) ? 7%
If diabetic and taking insulin or oral anti-diabetic therapy, must have hemoglobin A1c (HbA1c) =< 8%, or a fasting serum glucose =< 110% ULN
Glycated hemoglobin (HbA1c) =< 8%
Patients with poorly controlled diabetes mellitus with fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.
Non-fasting blood glucose >= 200 mg/dL, or hemoglobin A1C (HbA1C) >= 7%
Glycated hemoglobin (HbA1c) > 8%
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
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.
Diabetics are allowed if:\r\n* Fasting blood glucose (FBG) =< 130 mg/dL (mmol/L),\r\nOR\r\n* HbA1c =< 7%
Fasting glucose =< 126 mg/dL (7.0 mmol/L)
Fasting plasma glucose < 140 mg/dL/7.8 mmol/L
Fasting glucose under control (< 150 mg/dL [8.3 mmol/L])
Fasting plasma glucose < 140 mg/dL / 7.7 mmol/L and glycosylated hemoglobin (HbA1c) =< 8% (both criteria have to be met)
Fasting plasma glucose (FPG) =< 160 mg/dL or 7.8 mmol/L
Fasting plasma glucose =< 200 mg/dL
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
CERITINIB INCLUSION CRITERIA: Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
For patients without known type II diabetes, the following is required at screening:\r\n* Fasting plasma glucose =< 160 mg/dL (7.49 mmol/L) and glycosylated hemoglobin (HbA1c) < 7.5 % or International Federation of Clinical Chemistry (IFCC) < 53 mmol/mol
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
Known diabetes (type 1 or 2), fasting glucose > or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C > 6.5
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L) (Gedatolisib can cause hyperglycemia)
Fasting plasma glucose =< 120 mg/dL
Fasting plasma glucose (FPG) =< 140 mg/dL or =< 7.8 mmol/L
Fasting plasma glucose (FPG) =< 140mg/dL or =< 7.8 mmol/L
Patient has fasting plasma glucose (FPG) ?140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ? 6.4% (both criteria have to be met)
Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14mmol/L)
Glucose < 40 mg/dl (< 2.2 mmol/L) or > 250 mg/dl (> 14 mmol/L)
Subjects with fasting plasma glucose ? 125 mg/dL and HbA1c < 6.5 % at screening\n             Subjects with fasting plasma glucose ?150 mg/dL and HbA1c ? 7.0 % at screening for\n             the Diabetes Expansion Cohort.
Within 14 days of subject registration: Fasting plasma glucose =< 140 mg/dL or 7.8 mmol/L\r\n* (NOTE: Fasting whole blood glucose testing is acceptable if fasting plasma glucose is not feasible)
Fasting plasma glucose (FPG) =< 140 mg/dL
Fasting serum glucose < 126 mg/dl (7 mmol/l)
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
Fasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0%. Inclusion criteria only for patients entering phase Ib escalation and phase II:
Grade ?2 hypercholesterolemia (TC >300 mg/dL or >7.75 mmol/L) and/or hypertriglyceridemia (TG >300 mg/dL or >3.42 mmol/L) in the fasting state.
Fasting plasma glucose (FPG) =< 120 mg/dL or =< 6.7 mmol/L
Baseline fasting glucose of < 126 mg/dl (7 mmol/L)
Known diabetes (type 1 or 2) or baseline fasting glucose >= 126 mg/dl (7 mmol/L)
Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L, where fasting is defined as no food intake for 8 hours prior to measurement
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
At least 4 weeks (28 days) prior to registration: Fasting plasma glucose (FPG) < 140 mg/dL/7.8 mmol/L
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L), if not consider initiation of metformin treatment prior to study treatment
Obtained within 2 weeks from study entry: Fasting plasma glucose =< 140 mg/dL
ARM A: Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L); ARM B: Fasting plasma glucose =< 140 mg/dL (7.8 mmol/L); hemoglobin A1c (HbA1c) =< 8%; ARMS C and D: Fasting plasma glucose =< 150 mg/dL
Fasting blood glucose of ? 140 mg/dL (7.8 mmol/L).
Fasting blood glucose of ? 140 mg/dL (7.8 mmol/L).
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with Fasting Plasma Glucose (FPG) ? 140 mg/dL / 7.8 mmol/L
Fasting plasma glucose > 120mg/dL or > 6.7 mmol/L
Fasting glucose of ?126 mg/dL (7.0 mmol/L).
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L)
Glycated hemoglobin (HgbA1c) ? 7 %; Fasting Plasma Glucose (FPG) ? 7.0 mmol/L (125 mg/dL).
Fasting glucose > 7.0 mmol/L (126 mg/dL). or HbA1c > 6.4%.
Fasting glucose < 140 mg/dL (7.8 mmol/L).
Fasting plasma glucose < 8.9 mmol/L (< 160mg/dL) and HbA1C < 8%
Fasting plasma glucose (FPG) ? 120 mg/dL or ? 6.7 mmol/L
Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
Fasting plasma glucose (FPG) =< 120 mg/dL or 6.7 mmol/L
Fasting plasma glucose =< 175 mg/dL (=< 9.8 mmol/L) - if glucose is checked in the non fasting state and it is =< 175 mg/dL then this will be acceptable
Fasting plasma glucose < 120 mg/dL
Fasting glucose < grade 2 (=< 160 mg/dL or =< 8.9 mmol/L) without the use of antihyperglycemic agents
Fasting plasma glucose =< 130 mg/dL (or 7.2 mmol/L)
Patients with a history of or known diagnosis of diabetes according to national guidelines (fasting plasma glucose >= 126 mg/dL or random plasma glucose >= 200 mg/dL), as evidenced in laboratory values =< 3 months old
Fasting plasma glucose < 140 mg/dL/7.7 mmol/L
12 hour fasting glucose level < 7.0 mmol/L
No known diabetes (type 1 or 2) or baseline fasting glucose >= 7.0 mmol/L
Plasma glucose =< 200 mg/dL
Plasma glucose > 200 mg/dL