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 DiabetesPRONTO-PEDS - PRONTO-Peds

Eli Lilly and Company0 sites751 target enrollmentApril 12, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 12, 2019

End Date

July 2, 2021

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\[1] Male or female patients with T1D for at least 6 months and diagnosed by an endocrinologist (pediatric or adult), diabetes specialist, or a physician with expertise in treating pediatric patients with Type 1 diabetes.
•\[2] Are at least 1 to \<18 years of age.
•\[4] Have been treated with only one of the following rapid\-acting insulin analogs as part of an MDI regimen for at least the last 90 days:
•a. insulin lispro U\-100, or
•b. insulin aspart
•c. insulin glulisine or
•d. Fast acting insulin aspart (must be approved for use in children in accordance with the local product label)
•\[5] Have been treated with only one of the following basal insulins for at least the last 90 days:
•a. insulin glargine U\-100 (QD or BID), or
•b. insulin detemir U\-100 (QD or BID), or

•\[13] Have current hypoglycemic unawareness in the investigator’s opinion or have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia, indicated by coma or convulsion and/or use of intravenous glucose or glucagon) within 6 months prior to screening (Visit 1\).
•\[14] 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 (Visit 1\).
•\[15] Have any other clinically significant disorder or uncontrolled concomitant disease that, in the investigator's opinion, would preclude participation in the trial or pose a safety risk.
•\[24] Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within the last 90 days.
•\[25] 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 the last 90 days.
•\[26] Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins within the last 90 days.
•\[27] Have been treated by CSII regimen for \=14 days within the last 90 days.