None listed
Conditions
Interventions
3,5 mg MK-0767 Type of group
3.5 mg MK-0767 will be supplied
Group name:Placebo Type of group
It will be supplied with placebo of MK-0767
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Men and women not pregnant. Age> 21 and <78 years. Understand the study procedures and accept participation in the study by giving written informed consent. Compliance greater than or equal to 75% (measured by tablet count) with placebo treatment during the transition period, evaluated in Visit 4 / Day 1 / Randomization.
Exclusion criteria
Exclusion criteria: Patients with a history of type 1 diabetes mellitus, history of ketoacidosis and / or C-peptide <0.8 mg./mL Patients with a history of allergy, intolerance or hypersensitivity to troglitazone, rosiglitazone, or pioglitazone or other PPAR agonists and, including history of elevated liver function tests, jaundice or Hepatotoxicity associated with these treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The central laboratory will perform all lipid and glycemic tests, as well as all other laboratory tests specified in the study. Once the patient has been randomized for active therapy (Visit 4 / Day 1), all lipid and glycemic values. Measure:To evaluate the efficacy of MK-0767 in decreasing hemoglobin Aic (HbA1c) compared with placebo after 20 weeks of treatment. Timepoints:2 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The central laboratory will perform all lipid and glycemic tests, as well as all other laboratory tests specified in the study. Once the patient has been randomized for active therapy (Visit 4 / Day 1), all lipid and glycemic values. Measure:To evaluate the efficacy of MK-0767 in reducing plasmatic glucose in fasting (FPG) compared with placebo. Timepoints:2 week | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed