Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- Drug: BMS-820132Drug: Placebo
- Registration Number
- NCT01105429
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile)
- Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for at least 2 months
- Body Mass Index (BMI) of 18 to 40 kg/m2
- Fasting glucose in the range of 100-250 mg/dL
- Hemoglobin A1c (HbA1c) in the range of 6.5% -9.5%
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Exclusion Criteria
- Clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, or depression
- Past history of diabetic ketoacidosis and/or C-peptide < 1.0 ng/mL, hyperosmolar nonketotic syndrome, lactic acidosis, or recurrent hypoglycemia
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Smoking more than 10 cigarettes per day
- Recent drug or alcohol abuse
- Women who are pregnant or breastfeeding
- Positive urine screen for drugs of abuse
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-820132 (1.0 mg) or Placebo BMS-820132 - BMS-820132 (0.3 mg) or Placebo BMS-820132 - BMS-820132 (0.3 mg) or Placebo Placebo - BMS-820132 (1.0 mg) or Placebo Placebo - BMS-820132 (3 mg) or Placebo BMS-820132 - BMS-820132 (3 mg) or Placebo Placebo - BMS-820132 (10 mg) or Placebo BMS-820132 - BMS-820132 (10 mg) or Placebo Placebo - BMS-820132 (30 mg) or Placebo BMS-820132 - BMS-820132 (30 mg) or Placebo Placebo - BMS-820132 (75 mg) or Placebo BMS-820132 - BMS-820132 (75 mg) or Placebo Placebo - BMS-820132 (150 mg) or Placebo BMS-820132 - BMS-820132 (150 mg) or Placebo Placebo - BMS-820132 (300 mg) or Placebo BMS-820132 - BMS-820132 (300 mg) or Placebo Placebo - BMS-820132 (TBD) or Placebo BMS-820132 - BMS-820132 (TBD) or Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments Within 5 days of study drug administration
- Secondary Outcome Measures
Name Time Method Exposure to the investigational drug and its metabolites Within 2 days after study drug administration Pharmacodynamic activity of the investigational drug on biomarkers Within 2 days after study drug administration Excretion of the investigational drug and metabolites from the body Within 2 days after study drug administration
Trial Locations
- Locations (3)
Profil Institute For Clinical Research, Inc. (Picr)
🇺🇸Chula Vista, California, United States
Elite Research Institute
🇺🇸Miami, Florida, United States
Clinical Pharmacology Of Miami Inc.
🇺🇸Miami, Florida, United States