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Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

NCT03242252 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 787

Last updated 2021-06-25

Study results available
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Summary

Primary Objective:

To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment.

Secondary Objectives:

* To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight.
* To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Conditions

Interventions

DRUG

Placebo

Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral

DRUG

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally once daily. 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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2019-03-25
Completion
2019-10-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Colombia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Ukraine

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 NCT03242252 on ClinicalTrials.gov