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Efficacy and Tolerability of MK0533 in Patients With Type 2 Diabetes

This study has been terminated.
(This study is being discontinued based on data suggesting that none of the doses tested demonstrated both glycemic & body fluid benefits vs. the comparitor)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00543959
First received: October 5, 2007
Last updated: October 3, 2008
Last verified: October 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus Type 2
 Drug: MK0533
Drug: Comparator: Placebo (unspecified)
Drug: Comparator: pioglitazone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Efficacy and Tolerability Study of MK0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Body fluid gain from baseline after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part1 - Arm 1
Part1: Arm 1: drug
 Drug: 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.
Placebo Comparator: Part1 - Arm 2
Part1 - Arm 2: Pbo comparator
 Drug: Comparator: Placebo (unspecified)
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
Placebo Comparator: Part 2 - Arm 1
Part 2 - Arm 1: Pbo
 Drug: Comparator: Placebo (unspecified)
MK0533 Placebo; MK0533 5mg; MK0533 15mg; MK0533 30mg. Study period is a total of 24 wks.
Experimental: Part 2 - Arm 2
Part 2- Arm 2: drug 5mg
 Drug: 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.
Experimental: Part 2 - Arm 3
Part 2 - Arm 3: drug 15mg
 Drug: 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.
Experimental: Part 2 - Arm 4
Part 2 - Arm 4: drug 30mg
 Drug: 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.
Active Comparator: Part 2 - Arm 5
Part 2 - Arm 5: active comparator
 Drug: Comparator: pioglitazone
pioglitazone 45mg. Study period is a total of 24 wks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543959

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00543959     History of Changes
Other Study ID Numbers: 2007_544, MK0533-005
Study First Received: October 5, 2007
Last Updated: October 3, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013