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Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

NCT03285594 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

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 with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).

Secondary Objectives:

* To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
* To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
* To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.

Conditions

Interventions

DRUG

Sotagliflozin

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Insulin glargine (HOE901)

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Oral Antidiabetes Drugs (OADs)

OADs (including metformin) as prescribed by the investigator as per local labeling.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · 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
2017-09-15
Primary Completion
2019-09-17
Completion
2019-09-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Hungary
  • Slovakia
  • 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 NCT03285594 on ClinicalTrials.gov