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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part1 - Arm 1

Part1: Arm 1: drug

Group Type EXPERIMENTAL

MK0533

Intervention Type DRUG

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Part1 - Arm 2

Part1 - Arm 2: Pbo comparator

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.

Part 2 - Arm 1

Part 2 - Arm 1: Pbo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.

Part 2 - Arm 2

Part 2- Arm 2: drug 5mg

Group Type EXPERIMENTAL

MK0533

Intervention Type DRUG

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Part 2 - Arm 3

Part 2 - Arm 3: drug 15mg

Group Type EXPERIMENTAL

MK0533

Intervention Type DRUG

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Part 2 - Arm 4

Part 2 - Arm 4: drug 30mg

Group Type EXPERIMENTAL

MK0533

Intervention Type DRUG

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Part 2 - Arm 5

Part 2 - Arm 5: active comparator

Group Type ACTIVE_COMPARATOR

Comparator: pioglitazone

Intervention Type DRUG

pioglitazone 45mg. Study period is a total of 24 wks.

Interventions

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MK0533

Initially a 12-wk study of MK0533 30mg, switching at week 12 to a study of daily administration MK0533 5mg, MK0533 15mg, MK0533 30mg. Study period is a total of 24-wks.

Intervention Type DRUG

Comparator: Placebo (unspecified)

MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.

Intervention Type DRUG

Comparator: pioglitazone

pioglitazone 45mg. Study period is a total of 24 wks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No