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Clinical Trial Details

Trial ID: L3917
Source ID: NCT01703208
Associated Drug: Omarigliptin
Title: A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01703208/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Omarigliptin|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina), Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction \[MI\], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015., Up to 156 weeks|Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke), Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke)., Up to 179 weeks|Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke), Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event., Up to 179 weeks|Change From Baseline in Hemoglobin A1C (A1C) at Week 18, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C., Baseline and Week 18|Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin), A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C., Baseline and Week 18|Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 18|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to Week 18 | Secondary: Number of Participants With an Event of CV-Related Death, Participants with adjudicated and confirmed AEs of cardiovascular-related death., Up to 179 weeks|Number of Participants With an Event Per 100 Person-Years of CV-Related Death, Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event., Up to 179 weeks|Number of Participants With an Event of First MI (Fatal and Non-fatal), Participants with adjudicated and confirmed AEs of fatal and non-fatal MI., Up to 179 weeks|Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal), Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event., Up to 179 weeks|Number of Participants With an Event of Stroke (Fatal and Non-fatal), Participants with adjudicated and confirmed AEs fatal and non-fatal stroke., Up to 179 weeks|Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal), Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event., Up to 179 weeks|Number of Participants With an Event of All-Cause Death, All-cause death was death from any cause., Up to 179 weeks|Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death, All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event., Up to 179 weeks|Change From Baseline in A1C at Week 142, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C., Baseline and Week 142|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%)., 4 months|Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months, This change from baseline reflects the Month 4 FPG minus the Week 0 FPG., Baseline and 4 months|Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline, Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months., Up to 179 weeks|Percentage of Participants Who Experienced at Least One Adverse Event, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 234 weeks|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 212 weeks|Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin, This change from baseline reflects the Week 18 FPG minus the Week 0 FPG., Baseline and Week 18|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation., 18 weeks | Other: Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory), Participants with adjudicated and confirmed events of first hospitalization for heart failure., Up to 179 weeks|Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory), Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event., Up to 179 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 4202
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-10-05
Completion Date: 2017-03-22
Results First Posted: 2017-12-12
Last Update Posted: 2018-11-06
Locations:
URL: https://clinicaltrials.gov/show/NCT01703208