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

Organon and Co152 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Hypercholesterolemia

Interventions

EzetimibeDRUG

10 mg oral dose once daily for 24 weeks

PlaceboDRUG

Placebo to match ezetimibe orally once daily for 24 weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 24 weeks

Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

Data from ClinicalTrials.gov

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