None listed
Conditions
Interventions
Group 1 Type of group
1) Stages of transition and stabilization: 16 weeks. Patients will start with Glimepiride and Metformin, at varying doses according to clinical criteria. Doses will vary until a dose that meets the needs of the patient is found.
2) Transition Phase: 2 weeks. Placebo will be assigned. Keeping the usual doses of metformin and glimerpiride
3) Phase A: 24 weeks- The placebo will be replaced by MK-0431 100 mg four times a day. Continuing with the usual medication (Metformin and glimepiride)
1) Stages of transition and stabilization: 16 weeks. Patients will start with Glimepiride and Metformin, at varying doses according to clinical criteria. Doses will vary until a dose that meets the needs of the patient is found.
2) Transition Phase: 2 weeks. Placebo will be assigned. Keeping your usual doses of metformin and glimerpiride
3) Phase A: 24 weeks- Placebo MK-0431 100 mg four times a day. Continuing with the usual medication (Metformin and glimepiride)
4) Phase B: 30 weeks. P
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient suffers from diabetes mellitus type 2 (T2DM). b) The patient is> 18 and 10 weeks and has a HbAlc level> 7.5% and 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 7.5% and <10.5% measured at Visit 3 or within 2 weeks prior to this visit.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluacion clinica. 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 Measure:Safety of MK-0431 Timepoints:From the randomization: Day 1, Weeks 2, 3, 12, 18, 24, 54 | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name: HbA1C in blood Measure:Efficacy of MK-0431 Timepoints:From the randomization: Day 1, Weeks 2, 3, 12, 18, 24, 54 | — |
Countries
Austria, Czech Republic, Denmark, Iceland, Italy, Peru, Spain, Sweden
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed