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Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

NCT03066830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2021-05-11

Study results available
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Summary

Primary Objective:

To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.

Secondary Objectives:

* To compare Sotagliflozin 400 mg versus placebo based on:
* Change from baseline in fasting plasma glucose (FPG).
* Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Percentage of participants with HbA1c \<6.5% and \<7.0%.
* To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Conditions

Interventions

DRUG

Sotagliflozin (SAR439954)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Placebo

Pharmaceutical form: tablet Route of administration: oral

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

Sulfonylurea

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-24
Primary Completion
2019-04-17
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Estonia
  • Hungary
  • Poland
  • Romania
  • Slovakia
  • South Korea
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT03066830 on ClinicalTrials.gov