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Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

NCT02384941

CompletedPhase 3

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 1 Diabetes Mellitus

Interventions: Placebo, Sotagliflozin

Countries: United States, Canada

This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participants had given written informed consent to participate in the study in accordance with local regulations.
* Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
* At the Screening Visit, A1C must be between 7.0% to 11.0%.
* Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test .

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.
Locations (75)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Escondido, California, United States
  • Greenbrae, California, United States
  • Huntington Beach, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Palm Springs, California, United States
  • San Mateo, California, United States
  • Tarzana, California, United States
  • Tustin, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Longmont, Colorado, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • New Port Richey, Florida, United States
  • Ormond Beach, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Roswell, Georgia, United States
  • Honolulu, Hawaii, United States
  • Crystal Lake, Illinois, United States
  • Elgin, Illinois, United States
  • Springfield, Illinois, United States
  • Topeka, Kansas, United States
  • Lexington, Kentucky, United States
  • + 45 more on CT.gov