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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo

Drug: BMS-820132

Study type

Interventional

Funder types

Industry

Identifiers

NCT01290575

MB122-004

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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.

Full description

Study Classification: Safety, Pharmacokinetics/dynamics

Enrollment

67 patients

Sex

All

Ages

18 to 70 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 (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
Body Mass Index (BMI) of 18.5 to 40 kg/m2.
Fasting glucose in the range of 125-275 mg/dL.
Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
Fasting C-peptide > 1 ng/mL.

Exclusion criteria

Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
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 Human Immunodeficiency Virus (HIV)-1, -2 antibody.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

67 participants in 9 patient groups

Arm 1 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 2 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 3 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 4 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 5 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 6 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 7 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 8 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Arm 9 BMS-820132 or placebo

Active Comparator group

Treatment:

Drug: BMS-820132

Drug: Placebo

Trial contacts and locations

5

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