Dose-ranging Study in Patients With Type 1 Diabetes Mellitus (inTandem4)

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

NCT02459899

LX4211.206 (Other Identifier)

LX4211.1-206-T1DM

Details and patient eligibility

About

The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant 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 type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
• Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
• At the Screening Visit, A1C had to be between 7.0% and 10.0%.
• Females of childbearing potential had to 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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141 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.

Treatment:

Drug: Placebo

Sotagliflozin 75 mg

Experimental group

Description:

Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.

Treatment:

Drug: Placebo

Drug: Sotagliflozin

Sotagliflozin 200 mg

Experimental group

Description:

Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.

Treatment:

Drug: Placebo

Drug: Sotagliflozin

Sotagliflozin 400 mg

Experimental group

Description:

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.

Treatment:

Drug: Sotagliflozin