Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BMS-823778; Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01111955

MB121-002

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Drug naive or on stable metformin therapy
• HbA1c 7-10%
• FPG ≤ 240mg/dL

Exclusion criteria

• History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
• Congestive heart failure
• Active liver disease
• Impaired renal function
• Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 4 patient groups, including a placebo group

BMS-823778 (2 mg)

Active Comparator group

Description:

+ metformin

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Drug: Metformin

BMS-823778 (10 mg)

Active Comparator group

Description:

+ metformin

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Drug: Metformin

BMS-823778 (20 mg)

Active Comparator group

Description:

+ metformin

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Drug: Metformin

Placebo

Placebo Comparator group

Description:

+ metformin

Treatment:

Drug: Placebo

Drug: Metformin