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 Diabetes PRONTO-PEDS - PRONTO-Peds

Eli Lilly and Company0 个研究点目标入组 708 人开始时间: 2019年3月19日最近更新: 2019年12月10日

研究概览

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•[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
•c. insulin degludec U-100 (QD)
•[6] Use a total daily dose of insulin 0.5 to =1.5 U/kg.
•a.TDD can be the average of previous 3 to 7 days
•[7] Have an HbA1c value =6.5 and =9.5%, according to the central laboratory.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 708
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•[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.

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