Trial · NCT02558296
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 24 | 24 weeks | The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events. |
| Secondary | Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin | 24 weeks | To evaluate the effect of 20 mg bexagliflozin on the change in HbA1c from baseline to week 24 in randomized subjects who have been prescribed insulin to control their diabetes |
| Secondary | Change in Body Weight From Baseline to Week 48 | 48 weeks | To evaluate the effect of 20 mg bexagliflozin on the change in body weight from baseline to week 48 in randomized subjects with a BMI ≥ 25 kg/m2 compared to placebo |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline | 24 weeks | To evaluate the effect of 20 mg bexagliflozin on the change in systolic blood pressure (SBP) from baseline to week 24 in subjects with baseline systolic blood pressure ≥ 140 mmHg compared to placebo |
| Other | Change in HbA1c From Baseline Over Time | Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168 | To assess the effect of 20 mg bexagliflozin treatment on the change in HbA1c from baseline versus placebo over time up to 168 weeks |
| Other | Change in Fasting Plasma Glucose Over Time | Baseline (week 0) and weeks 6, 12, 24, 36, 48, 72, 96, 120, 144 and 168 | To evaluate the effect of bexagliflozin treatment on the change in fasting plasma glucose (FPG) versus placebo over time up to 168 weeks |
| Other | Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification | 24 week | To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period |
| Other | Proportion of Subjects Requiring an Intensification of Hypoglycemic Agent and Time to First Intensification | Duration of study (168 weeks) | To measure the proportion of subjects requiring an intensification of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study period |
| Other | Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent | 24 weeks | To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during 24 week period |
| Other | Proportion of Subjects Requiring a Relaxation of Hypoglycemic Agent | Duration of study (168 weeks) | To measure the proportion of subjects requiring a relaxation of hypoglycemic agent in the bexagliflozin arm versus placebo during the entire study |
| Other | Proportion of Participants With Incidence of Hospitalization for Heart Failure | Duration of study (168 weeks) | To measure the incidence of hospitalization for heart failure among all subjects and among subjects who have a history of heart failure at baseline |
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/NCT02558296/registered