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

Hypercholesterolemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611883
• Other study ID #: P06541
• Secondary ID: MK-0653-367
• Status: Completed
• Phase: Phase 4
• Start date: July 2, 2012
• Est. completion date: January 16, 2014

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 16, 2014
• Est. primary completion date: January 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe
10 mg oral dose once daily for 24 weeks
• Placebo
Placebo to match ezetimibe orally once daily for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Hemoglobin (HbA1c) From Baseline	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.	Baseline and Week 24
Secondary	Change in Glycoalbumin From Baseline	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.	Baseline and Week 24
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline	Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.	Baseline and Week 24
Secondary	Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"	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.	up to 24 weeks
Secondary	Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes	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.	Up to 24 weeks
Secondary	Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline	LDL-C levels measured at baseline and after 24 weeks of treatment	Baseline and Week 24
Secondary	Percent Change in Total Cholesterol (TC) From Baseline	TC levels measured at Baseline and after 24 weeks of treatment.	Baseline and Week 24
Secondary	Percent Change in Triglycerides From Baseline	Triglycerides levels measured at baseline and after 24 weeks of treatment.	Baseline and Week 24
Secondary	Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline	HDL-C levels measured at baseline and after 24 weeks of treatment.	Baseline and Week 24
Secondary	Percent Change in Non-HDL-cholesterol From Baseline	Non-HDL-C levels measured at baseline and after 24 weeks of treatment.	Baseline and Week 24