A study to compare an investigational ultra-rapid insulin, LY900014 with insulin lispro in children with type 1 diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-002371-18-PL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Study Completion: 2021-07-02
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

[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

Exclusion Criteria

[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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified