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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

CCR2 Antagonist

Intervention Type DRUG

Tablets, Oral, 50 mg, once daily, 12 weeks

A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, 0mg, once daily, 12 weeks

Interventions

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CCR2 Antagonist

Tablets, Oral, 50 mg, once daily, 12 weeks

Intervention Type DRUG

Placebo

Tablets, Oral, 0mg, once daily, 12 weeks

Intervention Type DRUG

Other Intervention Names

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BMS-741672

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No