NCT01611883

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

July 2, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 17, 2014

Completed
Last Updated

May 24, 2024

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

June 1, 2012

Results QC Date

December 9, 2014

Last Update Submit

May 9, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in Glycoalbumin From Baseline

    Baseline and Week 24

  • Change in Fasting Plasma Glucose (FPG) From Baseline

    Baseline and Week 24

  • Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"

    up to 24 weeks

  • Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes

    Up to 24 weeks

  • Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

    Baseline and Week 24

  • +4 more secondary outcomes

Study Arms (2)

Ezetimibe

EXPERIMENTAL

10 mg oral dose once daily for 24 weeks

Drug: Ezetimibe

Placebo

PLACEBO COMPARATOR

Placebo to match ezetimibe orally once daily for 24 weeks

Drug: Placebo

Interventions

EzetimibeDRUG

10 mg oral dose once daily for 24 weeks

Also known as: MK-0653, SCH 058235
Ezetimibe
PlaceboDRUG

Placebo to match ezetimibe orally once daily for 24 weeks.

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. 2015 May 1;14:40. doi: 10.1186/s12944-015-0036-z.

    PMID: 25929253RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 5, 2012

Study Start

July 2, 2012

Primary Completion

January 16, 2014

Study Completion

January 16, 2014

Last Updated

May 24, 2024

Results First Posted

December 17, 2014

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share