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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611883
First Posted: June 5, 2012
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    TC levels measured at Baseline and after 24 weeks of treatment.

  • Percent Change in Triglycerides From Baseline [ Time Frame: Baseline and Week 24 ]
    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 ]
    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 ]
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.


Enrollment: 152
Actual Study Start Date: July 2, 2012
Study Completion Date: January 16, 2014
Primary Completion Date: January 16, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01611883


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01611883     History of Changes
Other Study ID Numbers: P06541
MK-0653-367 ( Other Identifier: Merck Study Number )
First Submitted: June 1, 2012
First Posted: June 5, 2012
Results First Submitted: December 9, 2014
Results First Posted: December 17, 2014
Last Update Posted: May 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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