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

September 23, 2015 updated by: Bristol-Myers Squibb

A 12-Week Randomized, Double-Blinded Study to Evaluate the Effects of Daily Oral Doses of BMS-741672 in Drug-Naive Type 2 Diabetic Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Dzerzhnsky, Russian Federation, 140090
        • Local Institution
      • Moscow, Russian Federation, 105229
        • Local Institution
      • Moscow, Russian Federation, 125315
        • Local Institution
      • Moscow, Russian Federation, 117036
        • Local Institution
      • Nizhny Novgorod, Russian Federation, 603126
        • Local Institution
      • Saint Petersburg, Russian Federation, 191015
        • Local Institution
      • Saint Petersburg, Russian Federation, 195271
        • Local Institution
      • Saint-Petersburg, Russian Federation, 194044
        • Local Institution
      • Saint-Petersburg, Russian Federation, 190068
        • Local Institution
      • Tyumen, Russian Federation, 625023
        • Local Institution
      • Voronezh, Russian Federation, 394066
        • Local Institution
      • Yaroslavl, Russian Federation, 150023
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: CCR2 Antagonist
Tablets, Oral, 50 mg, once daily, 12 weeks
Other Names:
  • BMS-741672
Placebo Comparator: A2
Drug: Placebo
Tablets, Oral, 0mg, once daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: after 12 weeks of treatment
after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
Time Frame: throughout the 12 weeks of treatment
throughout the 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MB114-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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