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Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

CompletedPhase 2

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 1 Diabetes Mellitus

Interventions: Placebo, Sotagliflozin

Countries: United States

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participant 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 type 1 diabetes mellitus (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 injection (MDI).
* At the Screening Visit, A1C had to be between 7.0% and 10.0%.
* Females of childbearing potential had to 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 screening.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

Locations (17)

Concord, California, United States
Ventura, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Springfield, Illinois, United States
Metairie, Louisiana, United States
Auburn, Maine, United States
Rockville, Maryland, United States
Great Falls, Montana, United States
Omaha, Nebraska, United States
High Point, North Carolina, United States
Columbus, Ohio, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Chesapeake, Virginia, United States
Manassas, Virginia, United States