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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Treatments

Drug: Placebo

Drug: BMS-820132

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105429

MB122-002

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 9 patient groups

BMS-820132 (0.3 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (1.0 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (3 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (10 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (30 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (75 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (150 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (300 mg) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

BMS-820132 (TBD) or Placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Drug: Placebo

Drug: BMS-820132

Trial contacts and locations

3

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