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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1405

Last updated 2020-02-12

Study results available
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Summary

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Conditions

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

Interventions

DRUG

Sotagliflozin

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, MD · 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
2015-09-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Slovakia
  • South Africa
  • Spain
  • 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 NCT02531035 on ClinicalTrials.gov