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Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
This study has been completed.

First Received on June 17, 2008.   Last Updated on February 22, 2011   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00699790
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: CCR2 Antagonist
Drug: Placebo
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Medicines
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured [ Time Frame: throughout the 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: CCR2 Antagonist
Tablets, Oral, 50 mg, once daily, 12 weeks
Other Name: BMS-741672
Placebo Comparator: A2 Drug: Placebo
Tablets, Oral, 0mg, once daily, 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699790

Locations
Russian Federation
Local Institution
Dzerzhnsky, Russian Federation, 140090
Local Institution
Moscow, Russian Federation, 125315
Local Institution
Moscow, Russian Federation, 105229
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, 190068
Local Institution
Saint-Petersburg, Russian Federation, 194044
Local Institution
Tyumen, Russian Federation, 625023
Local Institution
Voronezh, Russian Federation, 394066
Local Institution
Yaroslavl, Russian Federation, 150023
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00699790     History of Changes
Other Study ID Numbers: MB114-005
Study First Received: June 17, 2008
Last Updated: February 22, 2011
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Bristol-Myers Squibb:
Diabetes
NOS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on February 09, 2012



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