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

Phase 1

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

• Registration Number: PER-020-03
• 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: 2003-03-18
• 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 of metformin (metformin or metformin-XR) that meet the following criteria will be incorporated for enrollment in this study. The criteria listed below will be evaluated at Visit 1 / Week -7, unless
Indicate otherwise. All laboratory measurements will be carried out
after a night time> 12 hours.

Exclusion Criteria

Patients with a history of type 1 diabetes mellitus, and / or a history of ketoacidosis, and / or C peptide <0.8 mg / mL (<0.26 nmol / L) who are currently being treated with insulin.
Patients with a history of allergies, intolerance or hypersensitivity to
troglitazone, rosiglitazone, pioglitazone, which includes a history of high liver function tests, jaundice or hepatotoxicity associated with these treatments.

Study & Design

• Study Type: Interventional
• Study Design: Not specified