A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
- 试验地点
- 111
- 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 reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents 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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1D for at least 6 months at the screening visit.
- •Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:
- •insulin lispro U-100, or
- •insulin aspart
- •insulin glulisine or
- •fast acting insulin aspart
- •Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:
- •insulin glargine U-100 (once a day [QD] or twice a day [BID]), or
- •insulin detemir U-100 (QD or BID), or
- •insulin degludec U-100 (QD)
- •Have a HbA1c value ≤ 9.9% at the screening visit.
排除标准
- •Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
- •Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
- •Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.
研究组 & 干预措施
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Lispro (Drug)
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Glargine (Drug)
Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Insulin Degludec (Drug)
LY900014
Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
干预措施: LY900014 (Drug)
LY900014 Postmeal
Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
干预措施: LY900014 (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
Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors. The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.
次要结局
- Percentage of Participants With Documented Hypoglycemic Events(Baseline through Week 26)
- Change From Baseline in HbA1c (Postprandial) at Week 26(Baseline, Week 26)
- Rate of Severe Hypoglycemia(Week 0 through Week 26)
- Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26(Baseline, Week 26)
- Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose(Baseline through Week 26)
- Change From Baseline in Insulin Dose at Week 26(Baseline, Week 26)
- Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose(Baseline through Week 26)
- Rate of Documented Hypoglycemia Events(Week 0 through Week 26)
- Percentage of Participants With HbA1c < 7.0% and <7.5%(Week 26)