A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1C (A1C) at Week 12
研究概览
简要总结
This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant had given written informed consent.
- •Young adult participants >=18 to <=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
- •Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
- •At Screening, must had A1C >= 9.0%.
- •Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
- •Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.
排除标准
- •Any prior use of LX4211/sotagliflozin.
- •Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
- •Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
- •Chronic systemic corticosteroid use.
- •Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
- •History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
- •History of severe hypoglycemic event within 1 month prior to the Screening Visit.
研究组 & 干预措施
Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
干预措施: Placebo (Drug)
Sotagliflozin 400 mg
Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
干预措施: Sotagliflozin (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
时间窗: Baseline, Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
次要结局
- Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12(Baseline, Week 12)
- Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12(Baseline, Week 12)
- Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12(Baseline, Week 12)
- Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12(Baseline, Week 12)