MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MK-0767 ADDED TO SULFONILUREA THERAPY IN PATIENTS WITH DIABETES MELLITUS TYPE 2 IMPROPERLY CONTROLLED

Not Applicable

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

• Registration Number: PER-018-03
• 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: 2003-03-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

Patients with type 2 diabetes with inadequate glycemic control in monotherapy with sulfonylurea that meet the following criteria will be incorporated for enrollment in the study. The criteria listed below will be evaluated in Visit 1 / Week -7, unless otherwise indicated. All laboratory measurements will be carried out after an overnight fast> 12 hours.

Exclusion Criteria

It excludes participation in the study of those individuals who comply with
any of the following criteria in Visit 1 / Week -7 (unless otherwise indicated). All laboratory measurements should be carried out after an overnight fast> 12 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:HbA1c<br>Measure:Efficacy of MK-0767 to reduce HbA1c compared to placebo after 20 weeks of treatment.<br>Timepoints:8 week<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Fasting plasma glucose<br>Measure:Efficacy of MK-0767 to reduce fasting plasma glucose (FPG) compared with placebo after 20 weeks of treatment.<br>Timepoints:4 week<br>