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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Sotagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01742208

LX4211.1-203-T1DM

LX4211.203 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Sotagliflozin 400 mg - Pioneer Group

Experimental group

Description:

Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Placebo - Expansion Group

Placebo Comparator group

Description:

Two placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.

Treatment:

Drug: Placebo

Sotagliflozin 400 mg - Expansion Group

Experimental group

Description:

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin