A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study theSafety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - ND

• Conditions: Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control; MedDRA version: 12.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus

• Registration Number: EUCTR2009-009517-18-IT
• Lead Sponsor: MERCK & CO., INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

All laboratory measurements are to be performed after an overnight fast ≥12 hours in
duration. Patients with laboratory screening values/findings not meeting protocol
inclusion criteria may, at the discretion of the investigator, have a single repeat
determination performed. If the repeat value satisfies the criterion, they may continue in
the screening process. Only the laboratory test(s) not meeting inclusion criteria should be
repeated (not the entire panel).
Patients must meet all of the following inclusion criteria to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All laboratory measurements are to be performed after an overnight fast ≥12 hours in
duration. Patients with screening values outside the ranges described in the protocol
may, at the discretion of the investigator, have one repeat value determination performed
and if the repeat value does not meet the exclusion criterion they may continue the
screening process. Only the specific out-of-range value/finding should be repeated (not
the entire panel).
Individuals are excluded from participation in the study if they meet any of the following
exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified