Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
Phase 2
Completed
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: CCR2 AntagonistDrug: Placebo
- Registration Number
- NCT00699790
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 CCR2 Antagonist - A2 Placebo -
- Primary Outcome Measures
Name Time Method Change in HbA1c after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured throughout the 12 weeks of treatment
Trial Locations
- Locations (1)
Local Institution
🇷🇺Yaroslavl, Russian Federation