Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02421510 | Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy | PHASE3 | COMPLETED | 782 | — | — | May 1, 2015 | Jun 23, 2017 | Feb 12, 2020 | 96 | Austria, Belgium +15 |
| NCT02384941 | Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy | PHASE3 | COMPLETED | 793 | — | — | Mar 1, 2015 | Feb 1, 2017 | Feb 12, 2020 | 75 | United States, Canada |
| NCT02459899 | Dose-ranging Study in Patients With Type 1 Diabetes Mellitus | PHASE2 | COMPLETED | 141 | — | — | Jul 1, 2015 | Aug 1, 2016 | Feb 12, 2020 | 17 | United States |
| NCT02383940 | Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C | PHASE2 | COMPLETED | 87 | — | — | Apr 1, 2015 | Sep 1, 2016 | Feb 12, 2020 | 15 | United States |
| NCT01742208 | Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus | PHASE2 | COMPLETED | 36 | — | — | Feb 1, 2013 | Jan 1, 2014 | Feb 12, 2020 | 7 | United States |
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. |
| Sotagliflozin 200 mg | EXPERIMENTAL | Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. |
| Sotagliflozin 400 mg | EXPERIMENTAL | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. |
| Sotagliflozin 200 milligrams (mg) | EXPERIMENTAL | Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period. |
| Sotagliflozin 75 mg | EXPERIMENTAL | Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks. |
| Sotagliflozin 400 mg - Pioneer Group | EXPERIMENTAL | Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration. |
| Placebo - Expansion Group | PLACEBO_COMPARATOR | Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration. |
| Sotagliflozin 400 mg - Expansion Group | EXPERIMENTAL | Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration. |
| Name | Type | Description |
|---|---|---|
| Sotagliflozin | DRUG | High dose Sotagliflozin, once daily, before the first meal of the day |
| Placebo | DRUG | Placebo, once daily, before the first meal of the day |
Inclusion Criteria: * Participant who gave written informed consent to participate in the study in accordance with local regulations. * Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. * Participants treated with insulin or insulin analog...