A DOUBLE-BLIND, RANDOMIZED STUDY CONTROLLED WITH ACTIVE COMPARATOR MK-0767 AND METFFORMINA IN PATIENTS THAT SUFFER FROM DIABETES TYPE 2 INAPPROPRIATE CONTROL OF DIET AND EXERCISES.
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-065-03
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Between 21 and 78 years old.
Men and women not pregnant.
Understanding of the study procedures and agreement to participate in it, providing written informed consent.
Compliance with placebo treatment during the transition phase greater than or equal to 75%
History of type 1 diabetes mellitus and / or history of ketoacidosis, peptide C <0.8 ng / mL (<0.26 nmol / L).
Patients requiring lipid-lowering agents, such as HMG-CoA reductase inhibitors (statins) other than open label simvastatin.
Patients requiring treatment with doses> 40 mg of simvastatin,> 20 mg / day of atorvastatin or equivalent doses of other HMG-CoA reductase inhibitors.
Patients under a regimen of estrogen replacement therapy or SERM (Selective Estrogen Receptor Modulator) who are expected to require significant adjustments of the regimen after Visit 1 / Week 9.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:All analytes will be evaluated after 12 hours of<br>fast:<br>(1) Glucose metabolism: FPG, HbAic and insulin.<br>(2) Lipid Metabolism: Total cholesterol and triglycerides; no HDL-C, LDL-C and HDL-C; apoproteins A-I and B, plasma and serum samples will be archived for possible further study of lipoprotein measurements, such as density and subclass, and inflammatory / hemostatic measures, such as CRP, fibrinogen or PAI-1.<br>Measure:Efficacy of MK-0767 to reduce HbA1c compared to metformin during 52 weeks of treatment.<br>Timepoints:after 12 hours<br>;<br>Outcome name:Monitoring of adverse events (including AE GI), clinical evaluation (including vital signs / body weight, physical examination), laboratory evaluation (including AST, ALT, CPK, biochemistry, hematology, urinalysis, urine pregnancy test ), and electrocardiography (ECG, local reading and reading in the central laboratory, nuclear).<br>Measure:Evaluate safety and tolerability of MK-0767.<br>Timepoints:weekly<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Metabolism of Lipids: Total cholesterol and triglycerides; no HDL-C, LDL-C and HDL-C; apoproteins A-I and B, plasma and serum samples will be archived for possible further study of lipoprotein measurements, such as density and subclass, and inflammatory / hemostatic measures, such as CRP, fibrinogen or PAI-1.<br>Measure:To evaluate the improvement in lipids with MK-0767 compared to metformin, in patients who do not receive therapy with statins, in Week 12.<br>Timepoints:after 12 horas<br>