A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone (inTandem3)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: High Level of Sugar (Glucose) in the Blood; Type 1 Diabetes Mellitus (T1DM)

Treatments: Drug: Sotagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531035

LX4211.312 (Other Identifier)

LX4211.1-312-T1DM

Details and patient eligibility

About

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Enrollment: 1,405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants had given written informed consent to participate in the study in accordance with local regulations
• Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
• Participants were being treated with insulin or insulin analog
• Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
• At the Screening Visit, A1C was between 7.0% to 11.0%
• Females of childbearing potential used an adequate method of contraception and had 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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1,405 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 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 24 weeks.

Treatment:

Drug: Sotagliflozin