Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem2)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Sotagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02421510

2014-005153-39 (EudraCT Number)

LX4211.1-310-T1DM

LX4211.310 (Other Identifier)

Details and patient eligibility

About

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Enrollment: 782 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant who gave written informed consent to participate in the study in accordance with local regulations.
• Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
• Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
• Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
• At the Screening Visit, A1C was between 7.0% to 11.0%.
• Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test.

Exclusion criteria

• Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
• Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
• Chronic systemic corticosteroid use.
• Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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782 participants in 3 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 24 weeks followed by a 28-week extension period.

Treatment:

Drug: Placebo

Sotagliflozin 200 mg

Experimental group

Description:

Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin

Sotagliflozin 400 mg

Experimental group

Description:

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Treatment:

Drug: Sotagliflozin

Drug: Sotagliflozin