Clinical trial NCT01611883: A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) From Baseline
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Glycoalbumin From Baseline
timeFrame: Baseline and Week 24
measure: Change in Fasting Plasma Glucose (FPG) From Baseline
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"
timeFrame: up to 24 weeks
measure: Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes
timeFrame: Up to 24 weeks
measure: Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
timeFrame: Baseline and Week 24
measure: Percent Change in Total Cholesterol (TC) From Baseline
timeFrame: Baseline and Week 24
measure: Percent Change in Triglycerides From Baseline
timeFrame: Baseline and Week 24
measure: Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline
timeFrame: Baseline and Week 24
measure: Percent Change in Non-HDL-cholesterol From Baseline
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Saito I, Azuma K, Kakikawa T, Oshima N, Hanson ME, Tershakovec AM. A randomized, double-blind, placebo-controlled study of the effect of ezetimibe on glucose metabolism in subjects with type 2 diabetes mellitus and hypercholesterolemia. Lipids Health Dis. 2015 May 1;14:40. doi: 10.1186/s12944-015-0036-z.