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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Collaborator: Sanofi
• Treatments: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

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.