Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Sotagliflozin; Placebo; Sotagliflozin
Intervention description: Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.; Participants received placebo-matching sotagliflozin tablets once daily for 29 days.; Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      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 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.