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

• Status: Completed
• Trial end date: 2014-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe

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