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

This study is ongoing, but not recruiting participants.

First Received: June 17, 2008 Last Updated: February 3, 2010 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
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

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Locations

Russian Federation
Local Institution
Moscow, Russian Federation, 125315
Local Institution
Saint Petersburg, Russian Federation, 191015
Local Institution
Saint Petersburg, Russian Federation, 195271
Local Institution
Yaroslavl, Russian Federation, 150023
Local Institution
Nizhny Novgorod, Russian Federation, 603126
Local Institution
Smolensk, Russian Federation, 214018
Local Institution
Tyumen, Russian Federation, 625023
Local Institution
Moscow, Russian Federation, 105229
Local Institution
Saint-Petersburg, Russian Federation, 194044
Local Institution
Voronezh, Russian Federation, 394066
Local Institution
Dzerzhnsky, Russian Federation, 140090
Local Institution
Moscow, Russian Federation, 117036
Local Institution
Moscow, Russian Federation, 117036
Local Institution
Moscow, Russian Federation, 117036
Local Institution
Saint-Petersburg, Russian Federation, 190068
Local Institution
St.Petersburg, Russian Federation, 197198

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB114-005
Study First Received:	June 17, 2008
Last Updated:	February 3, 2010
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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 04, 2010