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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00699790
Enrollment
58
Registered
2008-06-18
Start date
2009-02-28
Completion date
2009-12-31
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, NOS

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

Interventions

DRUGCCR2 Antagonist

Tablets, Oral, 50 mg, once daily, 12 weeks

DRUGPlacebo

Tablets, Oral, 0mg, once daily, 12 weeks

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in HbA1cafter 12 weeks of treatment

Secondary

MeasureTime frame
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measuredthroughout the 12 weeks of treatment

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026