None listed
Conditions
Interventions
Mk 0767 5 mg Type of group
MK-0767 will be administered as tablets to be taken once a day in the morning. Patients will continue with the established dose of metformin, as prescribed by their doctor.
Group name:placebo Type of group
The placebo of MK-0767 will be administered in the form of tablets to be taken once a day in the morning. Patients will continue with the established dose of metformin, as prescribed by their doctor.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes with inadequate glycemic control in monotherapy of metformin (metformin or metformin-XR) that meet the following criteria will be incorporated for enrollment in this study. The criteria listed below will be evaluated at Visit 1 / Week -7, unless Indicate otherwise. All laboratory measurements will be carried out after a night time> 12 hours.
Exclusion criteria
Exclusion criteria: Patients with a history of type 1 diabetes mellitus, and / or a history of ketoacidosis, and / or C peptide <0.8 mg / mL (<0.26 nmol / L) who are currently being treated with insulin. Patients with a history of allergies, intolerance or hypersensitivity to troglitazone, rosiglitazone, pioglitazone, which includes a history of high liver function tests, jaundice or hepatotoxicity associated with these treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c Measure:Efficacy of MK-0767 to reduce HbA1c compared to placebo after 20 weeks of treatment. Timepoints:20 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting plasma glucose (PPG) Measure:Efficacy of MK-0767 to reduce fasting plasma glucose (PPG) compared to placebo after 20 weeks of treatment. Timepoints:20 week | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed