Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

NCT02531035

CompletedPhase 3

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood

Interventions: Sotagliflozin, Placebo

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Colombia, Czechia

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

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 T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had 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 screening
* Chronic systemic corticosteroid use
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
Locations (135)
  • Concord, California, United States
  • Escondido, California, United States
  • La Jolla, California, United States
  • San Marcos, California, United States
  • Ventura, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • New Haven, Connecticut, United States
  • Orlando, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Macon, Georgia, United States
  • Roswell, Georgia, United States
  • New Orleans, Louisiana, United States
  • Rockville, Maryland, United States
  • Boston, Massachusetts, United States
  • Bloomfield Hills, Michigan, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Albany, New York, United States
  • The Bronx, New York, United States
  • Asheville, North Carolina, United States
  • Chapel Hill, North Carolina, United States
  • Greenville, North Carolina, United States
  • Morehead City, North Carolina, United States
  • Grand Forks, North Dakota, United States
  • Bend, Oregon, United States
  • Sioux Falls, South Dakota, United States
  • Austin, Texas, United States
  • San Antonio, Texas, United States
  • + 105 more on CT.gov