# 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

> **NCT02421510** · PHASE3 · COMPLETED · sponsor: **Lexicon Pharmaceuticals** · enrollment: 782 (actual)

## Conditions studied

- Type 1 Diabetes Mellitus

## Interventions

- **DRUG:** Sotagliflozin
- **DRUG:** Sotagliflozin
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02421510
- **Lead sponsor:** Lexicon Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-05
- **Primary completion:** 2016-11
- **Final completion:** 2017-06-23
- **Target enrollment:** 782 (ACTUAL)
- **Last updated:** 2020-02-12

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02421510

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT02421510. Licensed CC0.

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