A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hemoglobin A1C (A1C) at Week 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
Intervention: Placebo
Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Intervention: Placebo
Sotagliflozin 75 mg
Sotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Intervention: Sotagliflozin
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Intervention: Placebo
Sotagliflozin 200 mg
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Intervention: Sotagliflozin
Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
Intervention: Sotagliflozin
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Time Frame: Baseline to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Secondary Outcomes
- Absolute Change From Baseline in Body Weight to Week 12(Baseline to Week 12)
- Percent Change From Baseline in Body Weight to Week 12(Baseline to Week 12)
- Change From Baseline to Week 12 in Fasting Plasma Glucose(Baseline to Week 12)
- Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal(Baseline, Week 12)
- Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion(Baseline, Week 12)