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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Comparator: pioglitazone; Drug: MK0533; Drug: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543959

0533-005

2007_544

MK0533-005

Details and patient eligibility

About

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

Enrollment: 346 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 7 patient groups, including a placebo group

Part1 - Arm 1

Experimental group

Description:

Part1: Arm 1: drug

Treatment:

Drug: MK0533

Part1 - Arm 2

Placebo Comparator group

Description:

Part1 - Arm 2: Pbo comparator

Treatment:

Drug: Comparator: Placebo (unspecified)

Part 2 - Arm 1

Placebo Comparator group

Description:

Part 2 - Arm 1: Pbo

Treatment:

Drug: Comparator: Placebo (unspecified)

Part 2 - Arm 2

Experimental group

Description:

Part 2- Arm 2: drug 5mg

Treatment:

Drug: MK0533

Part 2 - Arm 3

Experimental group

Description:

Part 2 - Arm 3: drug 15mg

Treatment:

Drug: MK0533

Part 2 - Arm 4

Experimental group

Description:

Part 2 - Arm 4: drug 30mg

Treatment:

Drug: MK0533

Part 2 - Arm 5

Active Comparator group

Description:

Part 2 - Arm 5: active comparator

Treatment:

Drug: Comparator: pioglitazone