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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: CCR2 Antagonist; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699790

MB114-005

Details and patient eligibility

About

The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients

Enrollment: 58 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: CCR2 Antagonist

A2

Placebo Comparator group

Treatment:

Drug: Placebo