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

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ClinicalTrials.gov Identifier: NCT00543959
Recruitment Status : 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)
First Posted : October 15, 2007
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Body fluid gain from baseline after 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Fasting plasma glucose after 12 weeks [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543959


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543959     History of Changes
Other Study ID Numbers: 0533-005
MK0533-005
2007_544
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

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