Trials / Completed
CompletedNCT02384941
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
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 793 (actual)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo once daily, before first meal of the day. |
| DRUG | Sotagliflozin | Sotagliflozin once daily, before first meal of the day. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2016-09-01
- Completion
- 2017-02-01
- First posted
- 2015-03-10
- Last updated
- 2020-02-12
- Results posted
- 2019-11-25
Locations
75 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02384941. Inclusion in this directory is not an endorsement.