Overview

Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Criteria
Inclusion Criteria:

- Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%

- Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL

- BMI ≤ 40 kg/m2

Exclusion Criteria:

- Active tuberculosis

- Symptoms of poorly controlled diabetes

- History of diabetic ketoacidosis

- Significant cardiovascular history or gastrointestinal disorders

- History of unstable or rapidly progressing renal disease

- Active liver disease and/or significant abnormal liver function

- Abnormal chest x-ray at screening indicative of tuberculosis or other infection