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

• ClinicalTrials.gov Identifier: NCT01611883
• Recruitment Status: Completed
• First Posted: June 5, 2012
• Results First Posted: December 17, 2014
• Last Update Posted: February 9, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Ezetimibe; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: July 2, 2012
• Actual Primary Completion Date: January 16, 2014
• Actual Study Completion Date: January 16, 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ezetimibe; 10 mg oral dose once daily for 24 weeks	Drug: Ezetimibe; 10 mg oral dose once daily for 24 weeks; Other Names: MK-0653; SCH 058235
Placebo Comparator: Placebo; Placebo to match ezetimibe orally once daily for 24 weeks	Drug: Placebo; Placebo to match ezetimibe orally once daily for 24 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change in Glycated Hemoglobin (HbA1c) From Baseline [ Time Frame: 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 :

1. Change in Glycoalbumin From Baseline [ Time Frame: 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.
2. Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Baseline and Week 24 ]
   Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.
3. Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes" [ Time Frame: 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.
4. Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes [ Time Frame: 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.
5. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline [ Time Frame: Baseline and Week 24 ]
   LDL-C levels measured at baseline and after 24 weeks of treatment
6. Percent Change in Total Cholesterol (TC) From Baseline [ Time Frame: Baseline and Week 24 ]
   TC levels measured at Baseline and after 24 weeks of treatment.
7. Percent Change in Triglycerides From Baseline [ Time Frame: Baseline and Week 24 ]
   Triglycerides levels measured at baseline and after 24 weeks of treatment.
8. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline [ Time Frame: Baseline and Week 24 ]
   HDL-C levels measured at baseline and after 24 weeks of treatment.
9. Percent Change in Non-HDL-cholesterol From Baseline [ Time Frame: Baseline and Week 24 ]
   Non-HDL-C levels measured at baseline and after 24 weeks of treatment.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

More Information

Study Data/Documents: CSR Synopsis 

Publications of Results:

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01611883
• Other Study ID Numbers: P06541; MK-0653-367 ( Other Identifier: Merck Study Number )
• First Posted: June 5, 2012
• Results First Posted: December 17, 2014
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents