# Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

> **NCT03351478** · PHASE3 · COMPLETED · sponsor: **Lexicon Pharmaceuticals** · enrollment: 770 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

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

## Key facts

- **NCT ID:** NCT03351478
- **Lead sponsor:** Lexicon Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-11-27
- **Primary completion:** 2019-05-16
- **Final completion:** 2019-05-16
- **Target enrollment:** 770 (ACTUAL)
- **Last updated:** 2021-05-11

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03351478

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03351478, "Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT03351478. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*