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

A Phase 4 study testing Ezetimibe in people with Hypercholesterolemia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Ezetimibe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 152 participants
Where: No sites listed yet
Study dates: 2 Jul 2012to 16 Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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)

Conditions: Hypercholesterolemia
Being tested: Ezetimibe, Placebo
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EzetimibeDrug
Also called MK-0653, SCH 058235
10 mg oral dose once daily for 24 weeks
PlaceboDrug
Placebo to match ezetimibe orally once daily for 24 weeks.

Study groups in NCT01611883
Study group	Role	What they receive
Ezetimibe	Experimental	10 mg oral dose once daily for 24 weeks Receives: Drug: Ezetimibe
Placebo	Placebo comparator	Placebo to match ezetimibe orally once daily for 24 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 24

Secondary outcomes (9)

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.
Measured: Baseline and Week 24
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.
Measured: Baseline and Week 24
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.
Measured: up to 24 weeks
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.
Measured: Up to 24 weeks
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
LDL-C levels measured at baseline and after 24 weeks of treatment
Measured: Baseline and Week 24
Percent Change in Total Cholesterol (TC) From Baseline
TC levels measured at Baseline and after 24 weeks of treatment.
Measured: Baseline and Week 24
Percent Change in Triglycerides From Baseline
Triglycerides levels measured at baseline and after 24 weeks of treatment.
Measured: Baseline and Week 24
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline
HDL-C levels measured at baseline and after 24 weeks of treatment.
Measured: Baseline and Week 24
Percent Change in Non-HDL-cholesterol From Baseline
Non-HDL-C levels measured at baseline and after 24 weeks of treatment.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201216 Jan 2014

First posted5 Jun 2012 (estimated)
Study start2 Jul 2012
Primary completion16 Jan 2014
Study completion16 Jan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01611883
Sponsor's protocol ID: P06541
Other IDs: MK-0653-367
Status last verified: Feb 2022
First submitted: 1 Jun 2012
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 25929253

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01611883
Acronym / sponsor ID: P06541
Conditions: Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 2 Jul 2012 (actual)
Primary completion: 16 Jan 2014 (actual)
Study completion: 16 Jan 2014 (actual)
First posted: 5 Jun 2012 (estimated)
Results: Posted 17 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ezetimibe	Experimental	Drug: Ezetimibe10 mg oral dose once daily for 24 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo to match ezetimibe orally once daily for 24 weeks

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EzetimibeAlso: MK-0653, SCH 05823510 mg oral dose once daily for 24 weeks	Drug	Ezetimibe
PlaceboPlacebo to match ezetimibe orally once daily for 24 weeks.	Drug	Placebo

Primary outcome

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.

9 secondary outcomes

Change in Glycoalbumin From Baseline
Time frame: Baseline and Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline
Time frame: Baseline and Week 24
Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"
Time frame: up to 24 weeks
Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes
Time frame: Up to 24 weeks
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline
Time frame: Baseline and Week 24
Percent Change in Total Cholesterol (TC) From Baseline
Time frame: Baseline and Week 24
Percent Change in Triglycerides From Baseline
Time frame: Baseline and Week 24
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline
Time frame: Baseline and Week 24
Percent Change in Non-HDL-cholesterol From Baseline
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 17 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe	75	74
Placebo	77	76

Primary outcome: Change in Glycated Hemoglobin (HbA1c) From Baseline

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Ezetimibe n = 69	Placebo n = 75
Value	0.22 (0.11 to 0.34)	0.14 (0.03 to 0.25)

Ezetimibe vs Placebo: Difference in Least-squares Means: 0.08 (95% CI -0.07 to 0.23), Longitudinal analysis of covariance

Population analysed: Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe	2 of 75 (2.7%)	17 of 75 (22.7%)	Not reported
Placebo	5 of 77 (6.5%)	25 of 77 (32.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25929253Saito 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.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ezetimibe in people with Hypercholesterolemia, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Hemoglobin (HbA1c) From Baseline (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01611883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.