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.

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients with type 2 diabetes mellitus who require treatment with glibenclamide> 10 mg to <20 mg or at least half of the maximum dose and the maximum recommended dose of a sulphonylurea for at least 6 weeks are eligible. of the selection period or glibenclamide 20 mg during, at least 2 weeks before the selection period.
HbA1c> = 7.0% and <= 10.0% obtained at the screening visit
men and women from 18 to 70 years of age.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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