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A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

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Trial Profile

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms PRONTO-Pump-2
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 16 Aug 2021 According to FDA news release, the U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump based on results from this study.
  • 01 Jul 2021 Primary endpoint (Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16) has been met, as per results published in the Diabetes, Obesity and Metabolism.
  • 01 Jul 2021 Results assessing efficacy and safety of ultra rapid lispro (URLi) versus lispro (Humalog) in people with type 1 diabetes on continuous subcutaneous insulin infusion (CSII), published in the Diabetes, Obesity and Metabolism.

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