- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01611883
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
Conditions
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P06541
- MK-0653-367 (OTHER: Merck Study Number)
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.
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