A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF MK-0431 IN PATIENTS WITH DIABETES MELLITUS TYPE 2 WHO HAVE AN UNPROTECTED GLUCEMIC CONTROL WITH PIOGLITAZONE THERAPY
Not Applicable
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-054-04
- 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
a. The patient has type 2 diabetes mellitus.
b. The patient is> 18 years of age.
c. The patient understands the study procedures and agrees to participate in the study by providing written informed consent.
d. The patient is not pregnant or breastfeeding and does not plan to become pregnant during the course of the study or during the post-study follow-up period.
Exclusion Criteria
a. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
b. The patient required insulin within the previous 8 weeks.
c. The patient began a treatment with a medication to lose weight within the previous 8 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:HbA1c<br>Measure:Measurement of drug efficacy<br>Timepoints:week 24<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The collection of adverse events, physical examination, vital signs and body weight. laboratory will include blood chemistry (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase), hematology (including complete blood count, differential, and absolute neutrophil count), urinalysis, urine pregnancy test (performed on women potentially fertile), an ECG will also be performed.<br>Measure:Measurement of drug safety<br>Timepoints:week 24<br>