Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes (0533-005)

Phase 2

Terminated

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: MK0533

• Registration Number: NCT00543959
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to evaluate the effectiveness and tolerability of MK0533 and pioglitazone in patients with type 2 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-15
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Patients between the ages of 18 to 70 years with Type 2 diabetes who have not been able to adequately control their blood glucose levels
• Note: Only patients who have not been taking any antihyperglycemic medicine for 3 months will be screened

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Exclusion Criteria

• Patients taking any medicines that affect body fluid level such as a diuretic or water pill
• Patients taking niacin or other certain medications
• Patients with any of the following conditions: liver or kidney disease, poorly controlled high blood pressure, heart disease or certain blood disorders
• Patients with abnormal laboratory results from a blood test that will be given before each patient starts the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2 - Arm 2	MK0533	Part 2- Arm 2: drug 5mg
Part 2 - Arm 3	MK0533	Part 2 - Arm 3: drug 15mg
Part 2 - Arm 4	MK0533	Part 2 - Arm 4: drug 30mg
Part1 - Arm 1	MK0533	Part1: Arm 1: drug

Primary Outcome Measures

Name	Time	Method
Body fluid gain from baseline after 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose after 12 weeks	12 weeks