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

February 7, 2022 updated by: Organon and Co

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)

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ezetimibe
10 mg oral dose once daily for 24 weeks
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
Placebo to match ezetimibe orally once daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 24
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.
Baseline and Week 24
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.
up to 24 weeks
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.
Up to 24 weeks
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
Baseline and Week 24
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.
Baseline and Week 24
Percent Change in Triglycerides From Baseline
Time Frame: Baseline and Week 24
Triglycerides levels measured at baseline and after 24 weeks of treatment.
Baseline and Week 24
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.
Baseline and Week 24
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.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2012

Primary Completion (ACTUAL)

January 16, 2014

Study Completion (ACTUAL)

January 16, 2014

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (ESTIMATE)

June 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on Ezetimibe

3
Subscribe