NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

CompletedPhase 2

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 1 Diabetes Mellitus

Interventions: Sotagliflozin, Placebo, Sotagliflozin

Countries: United States

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adults \>=18 to \<=55 years of age
* Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
* Willing to refrain from using carbohydrate counting to adjust insulin during the study
* Willing and able to wear and operate a continuous glucose monitor
* Willing and able to self-assess blood glucose
* Willing and able to provide written informed consent.

Exclusion Criteria:

* History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
* Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
* Use of premixed insulin
* History of diabetic ketoacidosis within 1 year of screening
* Presence of active hepatic disease or clinically significant abnormal liver function tests
* History of chronic pancreatitis
* Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
* History of clinically significant cardiac arrhythmias within 1 year prior to screening
* Participants with congestive heart failure
* Participants with uncontrolled Stage III hypertension
* History of human immunodeficiency virus (HIV) or hepatitis C
* History of illicit drug or alcohol abuse within 12 months prior to Screening
* Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
* Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
* Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
* Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
* Participants who underwent major surgery within 6 months prior to Screening
* Inability or difficulty swallowing whole tablets or capsules
* Women who were pregnant or breastfeeding.

Locations (7)

Aurora, Colorado, United States
Atlanta, Georgia, United States
Baton Rouge, Louisiana, United States
Omaha, Nebraska, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Dallas, Texas, United States