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Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

NCT03386344 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2021-06-25

Study results available
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Summary

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Conditions

Interventions

DRUG

Sotagliflozin

Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet; Route of administration: Oral

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-05-22
Completion
2020-05-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Mexico
  • New Zealand
  • Russia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03386344 on ClinicalTrials.gov