# A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

> **NCT02531035** · PHASE3 · COMPLETED · sponsor: **Lexicon Pharmaceuticals** · enrollment: 1405 (actual)

## Conditions studied

- Type 1 Diabetes Mellitus (T1DM)
- High Level of Sugar (Glucose) in the Blood

## Interventions

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

## Key facts

- **NCT ID:** NCT02531035
- **Lead sponsor:** Lexicon Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-09
- **Primary completion:** 2017-04
- **Final completion:** 2017-04
- **Target enrollment:** 1405 (ACTUAL)
- **Last updated:** 2020-02-12

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02531035

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02531035, "A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT02531035. Licensed CC0.

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