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

Primary Purpose

Diabetes Mellitus Type 2

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MK0533

Comparator: Placebo (unspecified)

Comparator: pioglitazone

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

Part1 - Arm 1

Part1 - Arm 2

Part 2 - Arm 1

Part 2 - Arm 2

Part 2 - Arm 3

Part 2 - Arm 4

Part 2 - Arm 5

Arm Description

Part1: Arm 1: drug

Part1 - Arm 2: Pbo comparator

Part 2 - Arm 1: Pbo

Part 2- Arm 2: drug 5mg

Part 2 - Arm 3: drug 15mg

Part 2 - Arm 4: drug 30mg

Part 2 - Arm 5: active comparator

Outcomes

Primary Outcome Measures

Body fluid gain from baseline after 12 weeks

Secondary Outcome Measures

Fasting plasma glucose after 12 weeks

Full Information

NCT ID

NCT00543959

First Posted

October 5, 2007

Last Updated

June 22, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00543959

Brief Title

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

Official Title

An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Why Stopped

This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic & body fluid benefits vs. the comparitor

Study Start Date

June 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part1 - Arm 1

Arm Type

Experimental

Arm Description

Part1: Arm 1: drug

Arm Title

Part1 - Arm 2

Arm Type

Placebo Comparator

Arm Description

Part1 - Arm 2: Pbo comparator

Arm Title

Part 2 - Arm 1

Arm Type

Placebo Comparator

Arm Description

Part 2 - Arm 1: Pbo

Arm Title

Part 2 - Arm 2

Arm Type

Experimental

Arm Description

Part 2- Arm 2: drug 5mg

Arm Title

Part 2 - Arm 3

Arm Type

Experimental

Arm Description

Part 2 - Arm 3: drug 15mg

Arm Title

Part 2 - Arm 4

Arm Type

Experimental

Arm Description

Part 2 - Arm 4: drug 30mg

Arm Title

Part 2 - Arm 5

Arm Type

Active Comparator

Arm Description

Part 2 - Arm 5: active comparator

Intervention Type

Drug

Intervention Name(s)

MK0533

Intervention Description

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

Intervention Name(s)

Comparator: Placebo (unspecified)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: pioglitazone

Intervention Description

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

Primary Outcome Measure Information:

Title

Body fluid gain from baseline after 12 weeks

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Fasting plasma glucose after 12 weeks

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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