Clinical trialNCT02421510CompletedPhase 3Interventional

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

SponsorLexicon PharmaceuticalsEnrollment782Type 1 Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Sangeeta Sawhney, M.D.
Lexicon Pharmaceuticals, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

96 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria

Lexicon Investigational Site
Linz, Austria
Lexicon Investigational Site
Vienna, Austria
Lexicon Investigational Site
Vienna, Austria
Lexicon Investigational Site
Vienna, Austria
Lexicon Investigational Site
Vienna, Austria

Belgium

Lexicon Investigational Site
Antwerp, Belgium
Lexicon Investigational Site
Brussels, Belgium
Lexicon Investigational Site
Edegem, Belgium
Lexicon Investigational Site
Leuven, Belgium
Lexicon Investigational Site
Sint-Niklaas, Belgium

Bulgaria

Lexicon Investigational Site
Lovech, Bulgaria
Lexicon Investigational Site
Plovdiv, Bulgaria
Lexicon Investigational Site
Rousse, Bulgaria
Lexicon Investigational Site
Smolyan, Bulgaria
Lexicon Investigational Site
Sofia, Bulgaria
Lexicon Investigational Site
Varna, Bulgaria

France

Lexicon Investigational Site
Béziers, France
Lexicon Investigational Site
Dijon, France
Lexicon Investigational Site
Nantes, France
Lexicon Investigational Site
Nantes, France
Lexicon Investigational Site
Nîmes, France

Germany

Lexicon Investigational Site
Düsseldorf, Germany
Lexicon Investigational Site
Hamburg, Germany
Lexicon Investigational Site
Hamburg, Germany
Lexicon Investigational Site
Hanover, Germany
Lexicon Investigational Site
Mainz, Germany
Lexicon Investigational Site
Münster, Germany
Lexicon Investigational Site
Neuwied, Germany

Hungary

Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Budapest, Hungary
Lexicon Investigational Site
Gyula, Hungary
Lexicon Investigational Site
Hódmezővásárhely, Hungary
Lexicon Investigational Site
Zalaegerszeg, Hungary

Israel

Lexicon Investigational Site
Haifa, Israel
Lexicon Investigational Site
Holon, Israel
Lexicon Investigational Site
Jerusalem, Israel
Lexicon Investigational Site
Petah Tikva, Israel

56 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboSotagliflozin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2015
Primary completion: 30 Nov 2016
Completion: 23 Jun 2017
Last update posted: 12 Feb 2020
Registered enrollment: 782
Registry id: NCT02421510

Cross-registrations

EU-CTR / CTIS (EudraCT)2014-005153-39

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.