Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented history of T2DM
Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
Body mass index (BMI) 25 to 45 kg/m\^2, inclusive, at Screening
HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose
C-peptide ≥ 0.8 ng/mL at Screening
Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period
You may not be if
Type 1 diabetes mellitus
History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
History of severe hypoglycemia
Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
History of congestive heart failure
Corrected QT interval (QTc) \> 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \> 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) \> 3 x ULN and/or serum total bilirubin \> 2.0 mg/dL
Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization
Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days)
Treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
Treatment with simvastatin or lovastatin at a dose \> 20 mg or \> 40 mg daily, respectively, within 14 days prior to randomization
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