Trial · NCT03242018
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 From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo | Baseline to Week 26 | An analysis of covariance (ANCOVA) model was used for the analysis. |
| Secondary | Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 for All Participants | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| 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 | An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated. |
| Secondary | Percentage of Participants With HbA1c <6.5% at Week 26 | Week 26 | |
| Secondary | Percentage of Participants With HbA1c <7.0% at Week 26 | Week 26 | |
| 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 | An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). |
| Other | Percentage of Participants With Hypoglycemic Events | up to 56.3 weeks | Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\]. |
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/registered