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STUDY PHASE III, RANDOMIZED, MULTICENTRIC, DOUBLE-BLIND, CONTROLLED BY PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF BMS 298585, IN COMBINATION WITH GLIBENCLAMIDE IN PATIENTS WITH DIABETES MELLITUS TYPE 2 THAT HAVE INAPPROPRIATE GLYCEMIC CONTROL WITH SULFONILUREA AS MONOTHERAPY.

STUDY PHASE III, RANDOMIZED, MULTICENTRIC, DOUBLE-BLIND, CONTROLLED BY PLACEBO TO EVALUATE THE SAFETY AND EFFICACY OF BMS 298585, IN COMBINATION WITH GLIBENCLAMIDE IN PATIENTS WITH DIABETES MELLITUS TYPE 2 THAT HAVE INAPPROPRIATE GLYCEMIC CONTROL WITH SULFONILUREA AS MONOTHERAPY.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-038-03
Enrollment
24
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

2,5 mg BMS-298585 Type of group
2.5 mg BMS-298585 combined with glibenclamide 15 mg will be administered in patients with type 2 diabetes with inadequate glycemic control. Group name:Placebo Type of group
A placebo of BMS-298585 combined with glibenclamide 15 mg will be administered in patients with type 2 diabetes with inadequate glycemic control.

Sponsors

BRISTOL MYERS SQUIBB PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus who require treatment with glibenclamide> 10 mg to = 7.0% and <= 10.0% obtained at the screening visit men and women from 18 to 70 years of age.

Exclusion criteria

Exclusion criteria: 1) Symptomatic type 2 diabetes mellitus, defined as polyuria and polydipsia Accentuated, with weight loss greater than 10% in the last 3 months. 2) History of diabetic ketoacidosis, non-ketosis hyperosmolar coma or insulin treatment during the year prior to the selection period (with the exception of insulin therapy during hospitalization or during gestational diabetes). 3) Patients with contraindications for treatment, as mentioned in the BMS-298585 Researcher´s Manual or the glibenclamide package insert. 4) History of MI, coronary angioplasty or revascularization (bypass), disease or valvular repair, unstable angina pectoris, TIA or cerebrovascular accidents during the 6 months prior to study entry. 5) Uncontrolled hypertension (RAS> 180 mm Hg and / or DBP> 110 mm Hg). (The measurement can be repeated after the start of antihypertensive treatment). 6) Congestive heart failure, defined as classes III and IV of the Cardiology Association of New York.

Design outcomes

Primary

MeasureTime frame
Outcome name:HbA1c Measure:Change in HbA1c with respect to the baseline measurement until Week 24 in the short-term, double-blind treatment phase. Timepoints:24 week—

Secondary

MeasureTime frame
Outcome name:fasting glucose Measure:Fasting glucose change from the baseline measurement until Week 24 in the short-term, double-blind treatment phase. Timepoints:24 week—

Countries

Argentina, Brazil, France, Germany, Peru, Spain, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)