None listed
Conditions
Interventions
5 mg MK-0767 Type of group
5 mg of MK-0767 will be supplied in 52-week single compressed tablets.
Group name:Placebo Type of group
The placebo will be given in tablet form and will be administered in the morning and evening with meals for up to 52 weeks.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: History of type 1 diabetes mellitus and / or history of ketoacidosis, peptide C 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:All analytes will be evaluated after 12 hours of fast: (1) Glucose metabolism: FPG, HbAic and insulin. (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. Measure:Efficacy of MK-0767 to reduce HbA1c compared to metformin during 52 weeks of treatment. Timepoints:after 12 hours ; 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). Measure:Evaluate safety and tolerability of MK-0767. Timepoints:weekly | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. Timepoints:after 12 horas | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed