A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy (PRONTO-Pump-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Drug: Ultra-Rapid Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03830281

2015-005358-36 (EudraCT Number)

I8B-MC-ITRO (Other Identifier)

16315

Details and patient eligibility

About

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

Enrollment: 471 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with T1D and continuously using insulin for at least 1 year
• Have been using CSII therapy for a minimum of 6 months
• Currently treated with <100 Units of one of following rapid-acting analog insulin via CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting insulin aspart, insulin glulisine
• Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump for at least the past 90 days

Exclusion criteria

• Have hypoglycemia unawareness
• Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
• Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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471 participants in 2 patient groups

Insulin Lispro (Humalog)

Active Comparator group

Description:

Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.

Treatment:

Drug: Insulin Lispro

Ultra-Rapid Lispro

Experimental group

Description:

Participants received individual dose of 100 units per milliliter (U/mL) ultra rapid lispro by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.

Treatment:

Drug: Ultra-Rapid Lispro