Type 2 Diabetes
Conditions
Keywords
Diabetes, NOS
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
Interventions
Tablets, Oral, 50 mg, once daily, 12 weeks
Tablets, Oral, 0mg, once daily, 12 weeks
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | after 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured | throughout the 12 weeks of treatment |
Countries
Russia