Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Sotagliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02383940

LX4211.204 (Other Identifier)

LX4211.1-204-T1DM

Details and patient eligibility

About

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Enrollment: 87 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant had given written informed consent.
• Young adult participants >=18 to <=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
• Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
• At Screening, must had A1C >= 9.0%.
• Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
• Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Exclusion criteria

• Any prior use of LX4211/sotagliflozin.
• Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
• Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
• Chronic systemic corticosteroid use.
• Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
• History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
• History of severe hypoglycemic event within 1 month prior to the Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

87 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.

Treatment:

Drug: Placebo

Sotagliflozin 400 mg

Experimental group

Description:

Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.

Treatment:

Drug: Sotagliflozin