A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ADDITION OF THE TREATMENT WITH MK-0431EN PATIENTS WITH DIABETES MELLITUS TYPE 2 WHO HAVE AN INAPPROPRIATE GLYCEMIC CONTROL WITH METFORMIN THERAPY.

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-051-04
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-08-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a. The patient has type 2 diabetes mellitus.
b. The patient is between> 18 and <78 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 needed insulin within the previous 8 weeks.
c. The patient is in a program to lose weight and is not in the maintenance phase.
d. The patient started a therapy with medication to lose weight.

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:24 weeks<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 and urine pregnancy test.<br>Measure:measuring the safety of the drug<br>Timepoints:24 weeks<br>