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Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
This study is currently recruiting participants.
Verified by Bristol-Myers Squibb, March 2009
First Received: June 17, 2008   Last Updated: August 19, 2009   History of Changes
Sponsored by: 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
Type 2 Diabetes
 Drug: CCR2 Antagonist
Drug: Placebo
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes
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 ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A1: Experimental Drug: CCR2 Antagonist
Tablets, Oral, 50 mg, once daily, 12 weeks
A2: Placebo Comparator 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

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
Russian Federation
Local Institution Recruiting
Moscow, Russian Federation, 125315
Contact: Site 001            
Local Institution Recruiting
Saint Petersburg, Russian Federation, 191015
Contact: Site 002            
Local Institution Recruiting
Saint Petersburg, Russian Federation, 195271
Contact: Site 003            
Local Institution Recruiting
Yaroslavl, Russian Federation, 150023
Contact: Site 004            
Local Institution Recruiting
Nizhny Novgorod, Russian Federation, 603126
Contact: Site 005            
Local Institution Not yet recruiting
Smolensk, Russian Federation, 214018
Contact: Site 006            
Local Institution Recruiting
Tyumen, Russian Federation, 625023
Contact: Site 007            
Local Institution Recruiting
Moscow, Russian Federation, 105229
Contact: Site 008            
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 194044
Contact: Site 016            
Local Institution Recruiting
Voronezh, Russian Federation, 394066
Contact: Site 010            
Local Institution Recruiting
Dzerzhnsky, Russian Federation, 140090
Contact: Site 011            
Local Institution Recruiting
Moscow, Russian Federation, 117036
Contact: Site 012            
Local Institution Not yet recruiting
Moscow, Russian Federation, 117036
Contact: Site 013            
Local Institution Not yet recruiting
Moscow, Russian Federation, 117036
Contact: Site 014            
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 190068
Contact: Site 015            
Local Institution Not yet recruiting
St.Petersburg, Russian Federation, 197198
Contact: Site 009            
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
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: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: MB114-005
Study First Received: June 17, 2008
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00699790     History of Changes
Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Bristol-Myers Squibb:
Diabetes
NOS

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
 Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

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

ClinicalTrials.gov processed this record on August 28, 2009



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