A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes (PRONTO-Peds)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Drug: Insulin Degludec; Drug: LY900014; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03740919

16698

I8B-MC-ITSB (Other Identifier)

2018-002371-18 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 751 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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751 participants in 3 patient groups

Insulin Lispro (Humalog)

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin Degludec

Drug: Insulin Glargine

Drug: Insulin Lispro

LY900014

Experimental group

Description:

Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.

Treatment:

Drug: LY900014

LY900014 Postmeal

Experimental group

Description:

Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.

Treatment:

Drug: LY900014