Trial · NCT01703208
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Up to 156 weeks | 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. |
| Primary | Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Up to 179 weeks | Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke). |
| Primary | 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) | Up to 179 weeks | 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. |
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Baseline and 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. |
| Primary | Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) | Baseline and 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. |
| Primary | 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 | Up to Week 18 | 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. |
| Primary | 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 | Up to Week 18 | 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. |
| Secondary | Number of Participants With an Event of CV-Related Death | Up to 179 weeks | Participants with adjudicated and confirmed AEs of cardiovascular-related death. |
| Secondary | Number of Participants With an Event Per 100 Person-Years of CV-Related Death | Up to 179 weeks | 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. |
| Secondary | Number of Participants With an Event of First MI (Fatal and Non-fatal) | Up to 179 weeks | Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. |
| Secondary | Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal) | Up to 179 weeks | 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. |
| Secondary | Number of Participants With an Event of Stroke (Fatal and Non-fatal) | Up to 179 weeks | Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. |
| Secondary | Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal) | Up to 179 weeks | 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. |
| Secondary | Number of Participants With an Event of All-Cause Death | Up to 179 weeks | All-cause death was death from any cause. |
| Secondary | Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death | Up to 179 weeks | All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event. |
| Secondary | Change From Baseline in A1C at Week 142 | Baseline and 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. |
| Secondary | Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months | 4 months | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months | Baseline and 4 months | This change from baseline reflects the Month 4 FPG minus the Week 0 FPG. |
| Secondary | Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline | Up to 179 weeks | Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months. |
| Secondary | Percentage of Participants Who Experienced at Least One Adverse Event | Up to 234 weeks | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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