Trial Outcomes & Findings for A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541) (NCT NCT01611883)

NCT ID: NCT01611883

Last Updated: 2024-05-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 152 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2024-05-24

Participant Flow

Participant milestones

Measure	Ezetimibe 10 mg oral dose once daily for 24 weeks	Placebo Placebo to match ezetimibe orally once daily for 24 weeks
Overall Study STARTED	75	77
Overall Study COMPLETED	74	76
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Ezetimibe 10 mg oral dose once daily for 24 weeks	Placebo Placebo to match ezetimibe orally once daily for 24 weeks
Overall Study Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ezetimibe n=75 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=77 Participants Placebo to match ezetimibe orally once daily for 24 weeks	Total n=152 Participants Total of all reporting groups
Age, Continuous	59.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	60.0 years STANDARD_DEVIATION 9.7 • n=7 Participants	59.6 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Measure	Ezetimibe n=69 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=75 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Change in Glycated Hemoglobin (HbA1c) From Baseline	0.22 Percent Interval 0.11 to 0.34	0.14 Percent Interval 0.03 to 0.25

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Measure	Ezetimibe n=69 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=75 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Change in Glycoalbumin From Baseline	-0.02 Percent Interval -0.37 to 0.34	-0.02 Percent Interval -0.37 to 0.33

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.

Outcome measures

Measure	Ezetimibe n=69 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=75 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Change in Fasting Plasma Glucose (FPG) From Baseline	6.6 mg/dL Interval 1.1 to 12.1	11.4 mg/dL Interval 6.1 to 16.7

SECONDARY outcome

Timeframe: up to 24 weeks

Population: All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ezetimibe n=75 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=77 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"	9.3 Percentage of Participants	7.8 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: AST Population defined as all participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ezetimibe n=75 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=77 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes	9.3 Percentage of Participants	5.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.

LDL-C levels measured at baseline and after 24 weeks of treatment

Outcome measures

Measure	Ezetimibe n=74 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=76 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline	-22.79 Percent Change Interval -25.81 to -19.78	-1.75 Percent Change Interval -4.73 to 1.24

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.

TC levels measured at Baseline and after 24 weeks of treatment.

Outcome measures

Measure	Ezetimibe n=74 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=76 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percent Change in Total Cholesterol (TC) From Baseline	-15.01 Percent Change Interval -17.34 to -12.68	-1.47 Percent Change Interval -3.77 to 0.84

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.

Triglycerides levels measured at baseline and after 24 weeks of treatment.

Outcome measures

Measure	Ezetimibe n=74 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=76 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percent Change in Triglycerides From Baseline	-7.52 Percent Change Interval -14.97 to -0.08	3.83 Percent Change Interval -3.57 to 11.23

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.

HDL-C levels measured at baseline and after 24 weeks of treatment.

Outcome measures

Measure	Ezetimibe n=74 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=76 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline	3.86 Percent Change Interval 0.77 to 6.96	1.41 Percent Change Interval -1.64 to 4.47

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.

Non-HDL-C levels measured at baseline and after 24 weeks of treatment.

Outcome measures

Measure	Ezetimibe n=74 Participants 10 mg oral dose once daily for 24 weeks	Placebo n=76 Participants Placebo to match ezetimibe orally once daily for 24 weeks
Percent Change in Non-HDL-cholesterol From Baseline	-21.32 Percent Change Interval -24.05 to -18.59	-2.25 Percent Change Interval -4.95 to 0.45

Adverse Events

Ezetimibe

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ezetimibe n=75 participants at risk 10 mg oral dose once daily for 24 weeks	Placebo n=77 participants at risk Placebo to match ezetimibe orally once daily for 24 weeks
Cardiac disorders ANGINA PECTORIS	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	1.3% 1/77 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Cardiac disorders ANGINA UNSTABLE	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	1.3% 1/77 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Eye disorders CATARACT	1.3% 1/75 • Number of events 2 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	0.00% 0/77 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	1.3% 1/75 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	0.00% 0/77 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	1.3% 1/77 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	1.3% 1/77 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	1.3% 1/77 • Number of events 1 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Ezetimibe n=75 participants at risk 10 mg oral dose once daily for 24 weeks	Placebo n=77 participants at risk Placebo to match ezetimibe orally once daily for 24 weeks
Infections and infestations NASOPHARYNGITIS	14.7% 11/75 • Number of events 12 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	16.9% 13/77 • Number of events 15 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Infections and infestations PHARYNGITIS	0.00% 0/75 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	5.2% 4/77 • Number of events 6 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOGLYCAEMIA	2.7% 2/75 • Number of events 8 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	9.1% 7/77 • Number of events 14 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	9.3% 7/75 • Number of events 7 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.	7.8% 6/77 • Number of events 6 • up to 24 weeks for non-serious adverse events (AEs); up to 28 weeks for serious AEs All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
• Publication restrictions are in place

Restriction type: OTHER