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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02421510
• Date of registration: 15/04/2015
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals
• Public title: 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
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
• Date of first enrolment: May 2015
• Target sample size: 782
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02421510
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Bulgaria, France, Germany, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Sangeeta Sawhney, M.D.
• Affiliation: Lexicon Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Sotagliflozin

Drug: Placebo

Primary Outcome(s)

Change From Baseline in A1C at Week 24 [Time Frame: Baseline to Week 24]

Secondary Outcome(s)

Change From Baseline in Body Weight at Week 24 [Time Frame: Baseline to Week 24]

Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24 [Time Frame: Baseline to Week 24]

Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24 [Time Frame: Baseline to Week 24]

Percent Change From Baseline in Body Weight at Week 24 [Time Frame: Baseline to Week 24]

Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24 [Time Frame: Baseline to Week 24]

Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24 [Time Frame: Baseline to Week 24]

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline to Week 24]

Secondary ID(s)

2014-005153-39

LX4211.1-310-T1DM

LX4211.310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 30/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02421510