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A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01611883
First received: June 1, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.


Condition Intervention Phase
Hypercholesterolemia
 Drug: Ezetimibe
Drug: Placebo
 Phase 4

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: Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase4, Protocol No. 367 (Also Known as SCH 58235, P06541)

Resource links provided by NLM:

Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Glycoalbumin from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Change in Fasting Plasma Glucose (FPG) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Percent Change in Low-density Lipoprotein (LDL) Cholesterol from Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezetimibe Drug: Ezetimibe
10 mg oral dose once daily for 24 weeks
Other Names:
  • MK-0653
  • SCH 058235
Placebo Comparator: Placebo Drug: Placebo
Placebo to match ezetimibe orally once daily for 24 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
  • No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
  • No change in diet and exercise therapy within previous 4 weeks

Exclusion Criteria:

  • Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
  • Homozygous or heterozygous familial hypercholesterolemia
  • Previously received ezetimibe
  • Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
  • Hyperlipidemia caused by medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611883

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Japan
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center     81-3-6272-1957        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01611883     History of Changes
Other Study ID Numbers: P06541, MK-0653-367
Study First Received: June 1, 2012
Last Updated: March 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013