A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BMS-512148; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162305

MB102-003

Details and patient eligibility

About

The purpose of this clinical research study is to assess the safety of, exposure to, and biological effects of BMS-512148 in stable Type 2 diabetic subjects

Enrollment: 47 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive).
• Fasting glucose (FG) < - 240 mg/dL, while on metformin or antidiabetic diet alone.
• HbA1c (Hemoglobin A1c) in the range of 6.0-10.0%

Exclusion criteria

• Women of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: BMS-512148

Drug: BMS-512148

Drug: BMS-512148

2

Active Comparator group

Treatment:

Drug: BMS-512148

Drug: BMS-512148

Drug: BMS-512148

3

Active Comparator group

Treatment:

Drug: BMS-512148

Drug: BMS-512148

Drug: BMS-512148

4

Placebo Comparator group

Treatment:

Drug: Placebo