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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 782

Last updated 2020-02-12

Study results available
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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

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Sotagliflozin

High dose Sotagliflozin, once daily, before the first meal of the day

DRUG

Sotagliflozin

Low dose Sotagliflozin,once daily, before the first meal of the day

DRUG

Placebo

Placebo, once daily, before the first meal of the day

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sangeeta Sawhney, M.D. · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-11-30
Completion
2017-06-23

Countries

  • Austria
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02421510 on ClinicalTrials.gov