An Efficacy and Tolerability Study of MK-0533 in Patients with Type II Diabetes Mellitus Who Have Inadequate Glycemic Control.

• Conditions: Type II Diabetes; MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2006-002090-47-HU
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Male and post-menopausal female patients, ages 18 to 70 years with T2DM who demonstrate inadequate glycemic control (HbAic =7.5% and =10.0%) and maintain a stable fluid status or body weight. Patients up to 70 years of age may be enrolled with prior approval from the IRB/ERC Note: Only patients who have not been taking any antihyperglycemic agents for =12 weeks will be screened.
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

Patients with New York Heart Association Class I, II, III, or IV. Patients taking any treatment which may cause them not to maintain a stable fluid status or body weight. Patients taking NSAIDs, COX-2 inhibitors, niacin, a bile-acid binding resin, a fibrate agent or pharmacologic doses of corticosteroids. Patients with any of the following conditions: chronic myopathy, a progressive neurological or neuromuscular disorder, significant abnormal liver function, active liver or gallbladder disease, inadequately controlled hypertension, or a clinically important hematological disorder. Patients on a weight-loss program or medication. Patients with significant abnormal laboratory values for any of the following: CPK, serum creatinine, AST, ALT, proteinuria, TSH, hemoglobin, hematuria.

Study & Design

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