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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0653-367 | Other Identifier | Merck Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe | Experimental | 10 mg oral dose once daily for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo to match ezetimibe orally once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe | Drug | 10 mg oral dose once daily for 24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Fasting Plasma Glucose (FPG) From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25929253 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe | 10 mg oral dose once daily for 24 weeks |
| FG001 | Placebo | Placebo to match ezetimibe orally once daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe | 10 mg oral dose once daily for 24 weeks |
| BG001 | Placebo | Placebo to match ezetimibe orally once daily for 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ezetimibe | 10 mg oral dose once daily for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo to match ezetimibe orally once daily for 24 weeks. |
|
Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration. |
| 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. | 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. | 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 | Baseline and Week 24 |
| Percent Change in Total Cholesterol (TC) From Baseline | TC levels measured at Baseline and after 24 weeks of treatment. | Baseline and Week 24 |
| Percent Change in Triglycerides From Baseline | Triglycerides levels measured at baseline and after 24 weeks of treatment. | 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. | 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. | Baseline and Week 24 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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|
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| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | 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. | All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | 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. | AST Population defined as all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | 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 | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 24 |
|
|
|
|
| Secondary | Percent Change in Total Cholesterol (TC) From Baseline | TC levels measured at Baseline and after 24 weeks of treatment. | FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 24 |
|
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|
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| Secondary | Percent Change in Triglycerides From Baseline | Triglycerides levels measured at baseline and after 24 weeks of treatment. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 24 |
|
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| Secondary | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline | HDL-C levels measured at baseline and after 24 weeks of treatment. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 24 |
|
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|
| 2 |
| 75 |
| 17 |
| 75 |
| EG001 | Placebo | Placebo to match ezetimibe orally once daily for 24 weeks | 5 | 77 | 25 | 77 |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| CATARACT | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
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.
| D009750 |
| Nutritional and Metabolic Diseases |