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

Organon

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: Ezetimibe

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01611883

P06541

MK-0653-367 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

152 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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