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.
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-041-03
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1) Body Mass Index <41 kg / m2.
2) Patients with type 2 diabetes are eligible who have
required to be treated with metformin, in doses not less than 1500 mg nor
greater than 2550 mg during the last 6 weeks prior to selection.
3) HbAic> 7.0% and <10.0% obtained at the screening visit.
4) Fasting peptide c> 1.5 ng / mL.
5) average serum TG <600 mg / dL (6.78 mmol / L) obtained at the visit of
selection (in those patients with TG of> 600 and <1000 mg / dL,
can make a new determination).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method