Last reviewed · How we verify
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem2)
This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
Details
| Lead sponsor | Lexicon Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 782 |
| Start date | 2015-05 |
| Completion | 2017-06-23 |
Conditions
- Type 1 Diabetes Mellitus
Interventions
- Sotagliflozin
- Sotagliflozin
- Placebo
Primary outcomes
- Change From Baseline in A1C at Week 24 — Baseline to Week 24
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.
Countries
Austria, Belgium, Bulgaria, France, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom