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

Completed · Phase 3 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT02531035

Run by

Lexicon Pharmaceuticals

People needed

1405

Starts

2015-09-01

Expected to finish

2017-04-01

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lexicon Investigational Site — Escondido, California, United States
• Lexicon Investigational Site — La Jolla, California, United States
• Lexicon Investigational Site — San Marcos, California, United States
• Lexicon Investigational Site — Ventura, California, United States
• Lexicon Investigational Site — Walnut Creek, California, United States
• Lexicon Investigational Site — Aurora, Colorado, United States
• Lexicon Investigational Site — New Haven, Connecticut, United States
• Lexicon Investigational Site — Orlando, Florida, United States
• Lexicon Investigational Site — West Palm Beach, Florida, United States
• Lexicon Investigational Site — Atlanta, Georgia, United States
• Lexicon Investigational Site — Macon, Georgia, United States
• Lexicon Investigational Site — Roswell, Georgia, United States
• Lexicon Investigational Site — New Orleans, Louisiana, United States
• Lexicon Investigational Site — Rockville, Maryland, United States
• Lexicon Investigational Site — Boston, Massachusetts, United States
• Lexicon Investigational Site — Bloomfield Hills, Michigan, United States
• Lexicon Investigational Site — Omaha, Nebraska, United States
• Lexicon Investigational Site — Las Vegas, Nevada, United States
• Lexicon Investigational Site — Albany, New York, United States
• Lexicon Investigational Site — The Bronx, New York, United States
• Lexicon Investigational Site — Asheville, North Carolina, United States
• Lexicon Investigational Site — Chapel Hill, North Carolina, United States
• Lexicon Investigational Site — Greenville, North Carolina, United States
• Lexicon Investigational Site — Morehead City, North Carolina, United States
• Lexicon Investigational Site — Concord, California, United States

Full record on ClinicalTrials.gov

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