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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe<br>10 mg oral dose once daily for 24 weeks | Drug: Ezetimibe<br>* 10 mg oral dose once daily for 24 weeks<br>* Other names: SCH 058235;|
| Placebo Comparator: Placebo<br>Placebo to match ezetimibe orally once daily for 24 weeks | Drug: Placebo<br>* Placebo to match ezetimibe orally once daily for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 24 | 
| 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. | Baseline and Week 24 | 
| 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. | up to 24 weeks | 
| 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. | Up to 24 weeks | 
| Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline | LDL-C levels measured at baseline and after 24 weeks of treatment | Baseline and Week 24 | 
| Percent Change in Total Cholesterol (TC) From Baseline | TC levels measured at Baseline and after 24 weeks of treatment. | Baseline and Week 24 | 
| Percent Change in Triglycerides From Baseline | 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 | HDL-C levels measured at baseline and after 24 weeks of treatment. | Baseline and Week 24 | 
| Percent Change in Non-HDL-cholesterol From Baseline | Non-HDL-C levels measured at baseline and after 24 weeks of treatment. | Baseline and Week 24 |