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Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

NCT03332771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 954

Last updated 2021-05-11

Study results available
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Summary

Primary Objective:

To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin.

Secondary Objectives:

To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]).

* To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants.
* To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c.
* To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

Conditions

Interventions

DRUG

Sotagliflozin (SAR439954)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Glimepiride

Pharmaceutical form: capsule Route of administration: oral

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

DRUG

Placebo

Pharmaceutical form: tablet Route of administration: oral

DRUG

Placebo

Pharmaceutical form: capsule 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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-08-06
Completion
2019-09-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary
  • Slovakia

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 NCT03332771 on ClinicalTrials.gov