CompletedPhase 4

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

152 participantsStarted 2012-07-02

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Glycated Hemoglobin (HbA1c) From Baseline

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT01611883

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-01-16

Results submitted2014-12-09

View on ClinicalTrials.gov More Hypercholesterolemia trials