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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- Change From Baseline in A1C at Week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
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.
干预措施: Placebo (Drug)
Sotagliflozin 200 mg
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.
干预措施: Sotagliflozin (Drug)
Sotagliflozin 400 mg
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.
干预措施: Sotagliflozin (Drug)
结局指标
主要结局
Change From Baseline in A1C at Week 24
时间窗: Baseline to Week 24
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.
次要结局
- Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24(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(Baseline to Week 24)
- Change From Baseline in Body Weight at Week 24(Baseline to Week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline to Week 24)
- Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24(Baseline to Week 24)
- Percent Change From Baseline in Body Weight at Week 24(Baseline to Week 24)
- Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24(Baseline to Week 24)