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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699790
• Other study ID #: MB114-005
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: September 23, 2015
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• CCR2 Antagonist
Tablets, Oral, 50 mg, once daily, 12 weeks
• Placebo
Tablets, Oral, 0mg, once daily, 12 weeks

Locations

Country	Name	City	State
Russian Federation	Local Institution	Dzerzhnsky
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhny Novgorod
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Tyumen
Russian Federation	Local Institution	Voronezh
Russian Federation	Local Institution	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		after 12 weeks of treatment	No
Secondary	Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured		throughout the 12 weeks of treatment	No

External Links

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