Trial · NCT01703208
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events. | Participants | NUMBER |
| 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 | The analysis population included all randomized participants who took at least one dose of blinded trial medication. | Participants | NUMBER |
| 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 | The analysis population included all randomized participants who took at least one dose of blinded trial medication. | Participants/100 Person-years | NUMBER |
| PRIMARY | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Baseline and Week 18 | The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement. | Percent | LEAST_SQUARES_MEAN |
| 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 | The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement. | Percentage | LEAST_SQUARES_MEAN |
| 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 | The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication. | Percentage of participants | NUMBER |
| 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 | The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Event of CV-Related Death | Up to 179 weeks | The analysis population consisted of all randomized participants who received at least one dose of blinded study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Event Per 100 Person-Years of CV-Related Death | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants/100 person-years | NUMBER |
| SECONDARY | Number of Participants With an Event of First MI (Fatal and Non-fatal) | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal) | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants/100 person-years | NUMBER |
| SECONDARY | Number of Participants With an Event of Stroke (Fatal and Non-fatal) | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal) | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants/100 person-years | NUMBER |
| SECONDARY | Number of Participants With an Event of All-Cause Death | Up to 179 weeks | The analysis population included all randomized participants who took at least one dose of blinded trial medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death | Up to 179 weeks | The analysis population included all randomized participants who took at least one dose of blinded study medication. | Participants/100 Person-years | NUMBER |
| SECONDARY | Change From Baseline in A1C at Week 142 | Baseline and Week 142 | The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months | 4 months | Data for this efficacy endpoint was not collected, analyzed or summarized. | ||
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months | Baseline and 4 months | Data for this efficacy endpoint was not collected, analyzed or summarized. | ||
| SECONDARY | Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline | Up to 179 weeks | Data for this efficacy endpoint was not collected, analyzed or summarized. | ||
| SECONDARY | Percentage of Participants Who Experienced at Least One Adverse Event | Up to 234 weeks | The analysis population included all randomized participants who took at least one dose of blinded study medication. | Percentage of participants | NUMBER |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01703208/outcomes