A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
- Registration Number
- NCT01611883
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 152
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo to match ezetimibe orally once daily for 24 weeks Ezetimibe Ezetimibe 10 mg oral dose once daily for 24 weeks
- Primary Outcome Measures
Name Time Method Change in Glycated Hemoglobin (HbA1c) From Baseline Baseline and Week 24 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.
- Secondary Outcome Measures
Name Time Method Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline Baseline and Week 24 LDL-C levels measured at baseline and after 24 weeks of treatment
Change in Fasting Plasma Glucose (FPG) From Baseline Baseline and Week 24 Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.
Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes" up to 24 weeks 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.
Change in Glycoalbumin From Baseline Baseline and Week 24 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.
Percent Change in Total Cholesterol (TC) From Baseline Baseline and Week 24 TC levels measured at Baseline and after 24 weeks of treatment.
Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes Up to 24 weeks 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.
Percent Change in Triglycerides From Baseline Baseline and Week 24 Triglycerides levels measured at baseline and after 24 weeks of treatment.
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline Baseline and Week 24 HDL-C levels measured at baseline and after 24 weeks of treatment.
Percent Change in Non-HDL-cholesterol From Baseline Baseline and Week 24 Non-HDL-C levels measured at baseline and after 24 weeks of treatment.