Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance
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
1 other identifier
interventional
58
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Feb 2009
Shorter than P25 for phase_2 type-2-diabetes
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 12, 2015
September 1, 2015
10 months
June 17, 2008
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
after 12 weeks of treatment
Secondary Outcomes (1)
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
throughout the 12 weeks of treatment
Study Arms (2)
A1
EXPERIMENTALA2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Local Institution
Dzerzhnsky, 140090, Russia
Local Institution
Moscow, 105229, Russia
Local Institution
Moscow, 117036, Russia
Local Institution
Moscow, 125315, Russia
Local Institution
Nizhny Novgorod, 603126, Russia
Local Institution
Saint Petersburg, 190068, Russia
Local Institution
Saint Petersburg, 191015, Russia
Local Institution
Saint Petersburg, 194044, Russia
Local Institution
Saint Petersburg, 195271, Russia
Local Institution
Tyumen, 625023, Russia
Local Institution
Voronezh, 394066, Russia
Local Institution
Yaroslavl, 150023, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
February 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 12, 2015
Record last verified: 2015-09