A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ADDITION OF MK-0431 TO THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS TYPE 2 THAT HAVE AN IMPROPER CONTROL WITH GLIMEPIRIDE THERAPY ONLY OR IN COMBINATION WITH METFORMI
- Conditions
- -E11 Non-insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusE11
- Registration Number
- PER-021-05
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a) The patient suffers from diabetes mellitus type 2 (T2DM).
b) The patient is> 18 and <75 years of age.
c) The patient understands the study procedures and agrees to participate in the study.
d) The patient is not pregnant or nursing or plans to become pregnant during the entire study and the post-study follow-up period.
e) The patient is a man, or a woman whose chances of conceiving are very improbable.
f) The patient meets the following conditions: 1) The patient currently receives glimepiride (in doses of at least 4 mg / day) alone or in combination with metformin (in doses of at least 1500 mg / day) for> 10 weeks and has a HbAlc level> 7.5% and <10.5% in the Screening Visit / Visit 1. OR 2) The patient is not receiving any antihyperglycemic medication and has a HbAic level> 9% in the Screening / Visit 1 Visit OR 3) The patient is currently receiving glimepiride in doses of less than 4 mg / day or is receiving another agent of the sulfonylurea type as monotherapy and has an HbAic level> 7.5% at the Screening / Visit. OR 4) The patient is currently receiving monotherapy with any other oral antihyperglycaemic agent and has an HbAlc level> 7.5% at the Screening Visit / OR 1. OR 5) The patient is currently receiving oral combination therapy of antihyperglycemic agents and has a level of HbAic> 6.5% and <10.5% in the Screening Visit / Visit 1.
g) HbAic level> 7.5% and <10.5% measured at Visit 3 or within 2 weeks prior to this visit.
a) The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or requires insulin within the previous 8 weeks.
b) The patient is following a weight reduction program and is not in the maintenance phase.
c) The patient is receiving or is likely to require treatment with immunosuppressive / immunomodulatory agents.
d) The patient has undergone surgery within the previous 30 days or has scheduled major surgery.
e) The patient has received treatment with an investigational drug within the previous 8 weeks
f) The patient is hypersensitive to the use of glimepiride, sulfonylurea-type agents, or pioglitazone.
g) The patient is hypersensitive to metformin and will receive metformin during the study.
h) The patient has ALT or AST levels> 2.0 times the Upper Limit of Normal (ULN).
i) The patient will receive metformin during the study, and the serum creatinine level is> 1.4 mg / dL (123.8 pmol / L) in men and> 1.3 mg / dL (114.9 pmol / L) in women or creatinine clearance estimated is (using the Cockcroft-Gault formula) <60 mlVmin.
j) The patient presents new signs or symptoms or the worsening of of coronary heart disease within the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:<br>HbA1C in blood<br>Measure:Efficacy of MK-0431<br>Timepoints:From the randomization: Day 1, Weeks 2, 3, 12, 18, 24, 54<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Evaluacion clinica.<br>Analisis de laboratorio: Alanina aminotransferasa [ALT], aspartato aminotransferasa [AST], bilimibina total, fosfatasa alcalina, hemograma completo [CBC], diferencial y recuento absoluto de neutrofilos, analisis de orina y pruebas de embarazo en orina<br><br>Measure:Safety of MK-0431<br>Timepoints:From the randomization: Day 1, Weeks 2, 3, 12, 18, 24, 54<br>