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LEXICON Study

Objective

Status Enrolling

Condition Type 1 Diabetes Mellitus

Description

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes  Protocol # LX4211.312

Purpose

Proportion of patients withA1C < 7.0% at Week

Phase III

Key Inclusion Criteria

  1. Patient has given written informed consent to participate in the study in accordance with local regulations
  2. Adult patients 18 years and older with a diagnosis of Type 1 Diabetes Mellitus (T1DM) made at least 1 year prior to informed consent
  3. Patients are being treated with insulin or insulin analog
  4. Willing and able to perform self-monitoring of blood glucose and complete the study diary as required per protocol
  5. At the Screening Visit, A1C must be between 7.0% to 11.0%
  6. Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test

Key Exclusion Criteria

  1. Use of antidiabetic agent other than insulin or insulin analog at the time of screening
  2. Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening

  3. Chronic systemic corticosteroid use

  4. Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1DM as determined by Investigator

ClinicalTrials.gov Identifier

  NCT02531035

IRB Protocol Number
FM-021
Principal Investigator(s)
Eric Johnson, MD

Clinical Trial Categories

  • Diabetes
Sponsor(s)
Lexicon Pharmaceuticals, Inc.
Contact
Renee Hendrickson, RN CCRC at 701-780-1694
or rhendrickson@altru.org