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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Non-Insulin-Dependent

In brief

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.

Key facts

Study ID

NCT01105429

Run by

Bristol-Myers Squibb

People needed

56

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2011-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Profil Institute For Clinical Research, Inc. (Picr) — Chula Vista, California, United States
• Clinical Pharmacology Of Miami Inc. — Miami, Florida, United States
• Elite Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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