Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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%

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