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MULTICENTRIC STUDY, IN PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO, TO EVALUATE THE SAFETY AND EFFICACY OF BMS-298585 IN COMBINATION WITH METFORMIN, FOR THE TREATMENT OF INDIVIDUALS WITH DIABETES TYPE 2 THAT PRESENT AN INAPPROPRIATE CONTROL WITH METFORMIN AS MONOTHERAPY.

MULTICENTRIC STUDY, IN PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO, TO EVALUATE THE SAFETY AND EFFICACY OF BMS-298585 IN COMBINATION WITH METFORMIN, FOR THE TREATMENT OF INDIVIDUALS WITH DIABETES TYPE 2 THAT PRESENT AN INAPPROPRIATE CONTROL WITH METFORMIN AS MONOTHERAPY.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-041-03
Enrollment
8
Registered
2003-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

5 mg BMS-298585 Type of group
Double-blind treatment will be administered with BM.S-29.8585 orally plus metformin. Group name:placebo Type of group
Double-blind treatment with placebo will be administered orally plus metformin.

Sponsors

BRISTOL MYERS SQUIBB COMPANY,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Body Mass Index 7.0% and 1.5 ng / mL. 5) average serum TG 600 and <1000 mg / dL, can make a new determination).

Exclusion criteria

Exclusion criteria: 1) Symptomatic type 2 diabetes, defined by polyuria and poiidipsia with loss weighing more than 10% during the last three months. 2) History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, or insulin treatment within one year of selection. 3) Individuals who have contraindications to treatment as described explained in the Instructions for the Researcher of BI \ / IS-298585 or in the package insert for metformin.

Design outcomes

Primary

MeasureTime frame
Outcome name:HbA1c Measure:Change in baseline HbA1c in Week 24 (or in the last post-baseline measurement prior to that Week, if the evaluation of Week 24 is not available), during the double-blind, short-term phase. Timepoints:24 weeks

Secondary

MeasureTime frame
Outcome name:CRP Measure:Change in the value of high sensitivity C-reactive protein between its baseline level and that of Week 24, or in the last post-baseline measurement prior to that Week, if the evaluation of Week 24 is not available. Timepoints:24 weeks

Countries

Australia, Canada, France, Korea North, Mexico, Poland, Sweden, United Kindgdom, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)