A MULTICIENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 TO PATIENTS WITH TYPE 2 DIABETES THAT PRESENT INACCURATE GLYCEMIC CONTROL IN THE COMBINED THERAPY OF METFORMIN AND SULFONILUREA.
Phase 1
- Conditions
- -E14 Unspecified diabetes mellitusUnspecified diabetes mellitusE14
- Registration Number
- PER-014-03
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age> 21 and <78 years.
In stable doses of metformin and sulfonylurea for at least 2
weeks before Visit 2 / Week -6.
Understanding of study procedures and agreement of
participate in the study through informed consent
written.
Exclusion Criteria
Patients with a history of type 1 diabetes mellitus and / or history
of ketoacidosis and / or C-peptide <0.8 ng / mL (<0.26 nmol / L).
Patients with the following treatments for diabetes during the
8 weeks prior to Visit 1.
Patients with a history of allergy, intolerance or hypersensitivity to troglitazone, rosiglitazone, pioglitazone or other PPAR-agonists and including a history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:HbA1c<br>Measure:Efficacy of HbAic reduction of MK-0767 compared to placebo after 20 weeks of treatment.<br>Timepoints:20 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Fasting plasma glucose<br>Measure:Efficacy of fasting plasma glucose reduction (FPG) of MK-0767 compared to placebo after 20 weeks of treatment.<br>Timepoints:20 weeks<br>