A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 933
- 试验地点
- 40
- 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 purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
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 been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
- •Have been treated for at least 90 days prior to screening with:
- •Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
- •Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
- •Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:
- •Metformin
- •Dipeptidyl peptidase-4 (DPP-4) inhibitor
- •Sodium glucose cotransporter 2 (SGLT2) inhibitor
- •Sulfonylurea
- •Meglitinide
- •Alpha-glucoside inhibitor
- •Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
- •Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.
排除标准
- •Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
- •Have hypoglycemia unawareness as judged by the investigator.
- •Have had any episode of severe hypoglycemia within the 6 months prior to screening.
- •Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
- •Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.
研究组 & 干预措施
LY900014
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) 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
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) 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
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) 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
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Metformin (Drug)
LY900014
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: SGLT2 inhibitor (Drug)
Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial 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 with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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)
Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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)
Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Metformin (Drug)
Insulin Lispro (Humalog)
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: SGLT2 inhibitor (Drug)
LY900014 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Metformin (Drug)
LY900014 Maximum Extended Enrollment (MEE)
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: SGLT2 inhibitor (Drug)
Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial 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 with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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)
Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 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)
Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: Metformin (Drug)
Insulin Lispro (Humalog) MEE
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
干预措施: SGLT2 inhibitor (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 performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. 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
- Rate of Documented Symptomatic Hypoglycemia(Baseline through Week 26)
- Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26(Baseline, Week 26)
- Number of Participants With HbA1c <7%(Week 26)
- 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand(Week 26)
- Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26(Baseline, Week 26)
- 2-hour PPG Excursion During MMTT Efficacy Estimand(Week 26)
- Rate of Severe Hypoglycemia(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 Dose at Week 26(Baseline, Week 26)