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Completed

NCT Number: NCT00699790

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

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Dzerzhnsky, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCR2 Antagonist

Drug

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

Other names: BMS-741672

Placebo

Drug

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

Primary outcomes

  1. Change in HbA1c

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured

    Time frame: throughout the 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 18, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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