A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog, LY2963016, to Lantus® in Combination With Mealtime Insulin Lispro in Adult Chinese Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 20
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
研究概览
简要总结
The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).
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
- None
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
- •Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).
- •Have duration of T1DM ≥1 year.
- •Have HbA1c ≤11 %.
- •Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
- •Have a body mass index (BMI) ≤35 kilograms per meter squared.
排除标准
- •Exposure to an insulin glargine other than Lantus® within previous 30 days.
- •Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
- •Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
- •Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
- •Are pregnant, intend to become pregnant during the course of the study.
- •Women who are breastfeeding.
- •Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
- •Have congestive heart failure Class III and IV.
- •Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.
- •Have any active cancer.
- •Have a history or diagnosis of human immunodeficiency virus (HIV) infection.
- •Have presence of clinically significant gastrointestinal disease.
- •Have a history of renal transplantation, or are currently receiving renal dialysis.
- •Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.
研究组 & 干预措施
LY2963016 + Insulin Lispro
Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
干预措施: LY2963016 (Drug)
LY2963016 + Insulin Lispro
Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
干预措施: Insulin Lispro (Drug)
Lantus® + Insulin Lispro
Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
干预措施: Lantus® (Drug)
Lantus® + Insulin Lispro
Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®)
时间窗: Baseline, Week 24
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).
次要结局
- Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016)(Baseline, Week 24)
- Percentage of Participants With HbA1c ≤6.5%(Week 24)
- Change From Baseline in Glycemic Variability of Fasting Blood Glucose(Baseline, Week 24)
- Number of Participants With Detectable Anti-Glargine Antibodies(Baseline through Week 24)
- Rate of Documented Symptomatic Hypoglycemia(Baseline through Week 24)
- Percentage of Participants With HbA1c <7%(Week 24)
- Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ)(Baseline, Week 24)
- Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values(Baseline, Week 24)
- Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG(Baseline, Week 24)
- Change From Baseline in Basal Insulin Dose(Baseline, Week 24)
- Change From Baseline in Prandial Insulin Dose(Baseline, Week 24)
- Change From Baseline in Body Weight(Baseline, Week 24)