A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro With an Open-Label Postprandial LY900014 Treatment Group, in Combination With Insulin Glargine or Insulin Degludec, in Adults With Type 1 Diabetes PRONTO-T1D
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,392
- 试验地点
- 51
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).
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
- Double (Participant, Investigator)
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 T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
- •HbA1c of ≥7.0 and ≤9.5%.
- •Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
- •Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
排除标准
- •Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
- •Have had more than 1 severe hypoglycemic episode within 6 months of screening.
- •Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
- •Have clinically significant gastrointestinal disease.
研究组 & 干预措施
LY900014
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: LY900014 (Drug)
LY900014
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
LY900014
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
Insulin Lispro (Humalog)
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Lispro (Drug)
Insulin Lispro (Humalog)
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
Insulin Lispro (Humalog)
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
LY900014 Postmeal (Open Label)
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: LY900014 (Drug)
LY900014 Postmeal (Open Label)
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
LY900014 Postmeal (Open Label)
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
LY900014 - Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: LY900014 (Drug)
LY900014 - Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
LY900014 - Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
Insulin Lispro (Humalog)-MEE
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Lispro (Drug)
Insulin Lispro (Humalog)-MEE
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
Insulin Lispro (Humalog)-MEE
Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
LY900014 Postmeal (Open Label)-MEE
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: LY900014 (Drug)
LY900014 Postmeal (Open Label)-MEE
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
LY900014 Postmeal (Open Label)-MEE
LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
次要结局
- Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26(Baseline, Week 26)
- Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26(Baseline, Week 26)
- Rate of Severe Hypoglycemia at Week 26(Baseline through Week 26)
- Rate of Documented Symptomatic Hypoglycemia at Week 26(Baseline through Week 26)
- Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26(Baseline, Week 26)
- Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26(Baseline, Week 26)
- Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26(Baseline, Week 26)
- Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26(Baseline, Week 26)
- Percentage of Participants With HbA1c <7%(Week 26)
- Change From Baseline in HbA1c at Week 52(Baseline, Week 52)
- Change From Baseline in Insulin Dose at Week 26(Baseline, Week 26)