A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MONOTHERAPY WITH MK-0431 IN PATIENTS WITH DIABETES MELLITUS TYPE 2 WHO HAVE AN INAPPROPRIATE GLYCEMIC CONTROL.
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsNon-insulin-dependent diabetes mellitus, without complicationsE119
- Registration Number
- PER-050-04
- 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
a. The patient suffers from type 2 diabetes mellitus (T2DM).
b. The patient is> 18 to <75 years of age.
c. The patient understands the study procedures and agrees to participate in the study by giving 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 follow-up period after the study.
a. The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
b. The patient required insulin within a previous period of 8 weeks.
c. The patient is in a weight loss program and is not in the maintenance phase.
d. The patient began a treatment with a medication to lose weight within a previous period of 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:14 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:the collection of adverse events, physical examination, vital signs and body weight. Laboratory safety studies will include a blood chemistry (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin, alkaline phosphatase, and creatine phosphokinase [CPK], hematology (including whole blood count [CBC], differential, and absolute neutrophil count), urinalysis and urine pregnancy test (performed on potentially fertile women) An ECO will be performed and read at the central laboratory.<br>Measure:Drug safety measurements<br>Timepoints:14 day<br>