Trial · NCT03242018
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo | Baseline to Week 26 | Intent-to-treat (ITT) population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo | Baseline to Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Baseline to Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 | Baseline to Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg | Baseline to Week 12 | Analysis population included all participants with baseline SBP ≥130 mmHg in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 12 for All Participants | Baseline to Week 12 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data are imputed using control-based copy reference multiple imputation under the missing not at random framework. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g) | Baseline to Week 26 | Analysis population included all participants with baseline UACR \> 30 mg/g in ITT population where, ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. Missing data was imputed using the retrieved dropouts \& washout imputation method. | percent change | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <6.5% at Week 26 | Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c <7.0% at Week 26 | Week 26 | ITT population included all randomized participants, irrespective of compliance with the study protocol and procedures. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks | Safety population included all randomized participants who received at least one dose of double-blind IMP. Two participants were randomized to Sotagliflozin 400 mg and dosed with Sotagliflozin 200 mg and 400 mg treatments during the study. Data for these participants were summarized in the Sotagliflozin 200 mg arm in the safety population. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Hypoglycemic Events | up to 56.3 weeks | Safety population included all randomized participants who received at least 1 dose of double-blind investigational medicinal product (IMP) (regardless of the amount of treatment administered). | 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/NCT03242018/outcomes