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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ezetimibe

    Placebo

    Arm Description

    10 mg oral dose once daily for 24 weeks

    Placebo to match ezetimibe orally once daily for 24 weeks

    Outcomes

    Primary Outcome Measures

    Change in Glycated Hemoglobin (HbA1c) From Baseline
    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
    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
    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"
    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
    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
    LDL-C levels measured at baseline and after 24 weeks of treatment
    Percent Change in Total Cholesterol (TC) From Baseline
    TC levels measured at Baseline and after 24 weeks of treatment.
    Percent Change in Triglycerides From Baseline
    Triglycerides levels measured at baseline and after 24 weeks of treatment.
    Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline
    HDL-C levels measured at baseline and after 24 weeks of treatment.
    Percent Change in Non-HDL-cholesterol From Baseline
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.

    Full Information

    First Posted
    June 1, 2012
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01611883
    Brief Title
    A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2, 2012 (Actual)
    Primary Completion Date
    January 16, 2014 (Actual)
    Study Completion Date
    January 16, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ezetimibe
    Arm Type
    Experimental
    Arm Description
    10 mg oral dose once daily for 24 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo to match ezetimibe orally once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ezetimibe
    Other Intervention Name(s)
    MK-0653, SCH 058235
    Intervention Description
    10 mg oral dose once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to match ezetimibe orally once daily for 24 weeks.
    Primary Outcome Measure Information:
    Title
    Change in Glycated Hemoglobin (HbA1c) From Baseline
    Description
    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.
    Time Frame
    Baseline and Week 24
    Secondary Outcome Measure Information:
    Title
    Change in Glycoalbumin From Baseline
    Description
    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.
    Time Frame
    Baseline and Week 24
    Title
    Change in Fasting Plasma Glucose (FPG) From Baseline
    Description
    Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"
    Description
    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.
    Time Frame
    up to 24 weeks
    Title
    Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes
    Description
    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.
    Time Frame
    Up to 24 weeks
    Title
    Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
    Description
    LDL-C levels measured at baseline and after 24 weeks of treatment
    Time Frame
    Baseline and Week 24
    Title
    Percent Change in Total Cholesterol (TC) From Baseline
    Description
    TC levels measured at Baseline and after 24 weeks of treatment.
    Time Frame
    Baseline and Week 24
    Title
    Percent Change in Triglycerides From Baseline
    Description
    Triglycerides levels measured at baseline and after 24 weeks of treatment.
    Time Frame
    Baseline and Week 24
    Title
    Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline
    Description
    HDL-C levels measured at baseline and after 24 weeks of treatment.
    Time Frame
    Baseline and Week 24
    Title
    Percent Change in Non-HDL-cholesterol From Baseline
    Description
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.
    Time Frame
    Baseline and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25929253
    Citation
    Saito I, Azuma K, Kakikawa T, Oshima N, Hanson ME, Tershakovec AM. A randomized, double-blind, placebo-controlled study of the effect of ezetimibe on glucose metabolism in subjects with type 2 diabetes mellitus and hypercholesterolemia. Lipids Health Dis. 2015 May 1;14:40. doi: 10.1186/s12944-015-0036-z.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=P06541&kw=P06541&tab=access

    Learn more about this trial

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

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