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A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

NCT03242018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2021-06-25

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 at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

* To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c
* To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo
* To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Conditions

Interventions

DRUG

Placebo

Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.

DRUG

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally, once daily.

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
2017-08-16
Primary Completion
2019-05-16
Completion
2019-12-11
FDA Drug
Yes

Countries

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

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 NCT03242018 on ClinicalTrials.gov