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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01611883
First received: June 1, 2012
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.


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 - Phase 4, Protocol No. 367 (Also Known as SCH 58235, P06541)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Glycated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.


Secondary Outcome Measures:
  • Change in Glycoalbumin From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration.

  • Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.

  • Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes" [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    The Investigator took into account a participant's index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant's diabetes and to determine if the participant's diabetes worsened. Participants who experienced the AE "Exacerbation of Diabetes " (verbatim term) were recorded.

  • Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized.

  • Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    LDL-C levels measured at baseline and after 24 weeks of treatment

  • Percent Change in Total Cholesterol (TC) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    TC levels measured at Baseline and after 24 weeks of treatment.

  • Percent Change in Triglycerides From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Triglycerides levels measured at baseline and after 24 weeks of treatment.

  • Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    HDL-C levels measured at baseline and after 24 weeks of treatment.

  • Percent Change in Non-HDL-cholesterol From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.


Enrollment: 152
Study Start Date: July 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezetimibe
10 mg oral dose once daily for 24 weeks
Drug: Ezetimibe
10 mg oral dose once daily for 24 weeks
Other Names:
  • MK-0653
  • SCH 058235
Placebo Comparator: Placebo
Placebo to match ezetimibe orally once daily for 24 weeks
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611883

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01611883     History of Changes
Other Study ID Numbers: P06541, MK-0653-367
Study First Received: June 1, 2012
Results First Received: December 9, 2014
Last Updated: June 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 02, 2015