A study to compare an investigational ultra-rapid insulin, LY900014 with another mealtime insulin, Fiasp when both are used along with a long-acting insulin in people with type 1 diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-003399-30-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-23
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 632

Inclusion Criteria

• You are diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months
• You are 18 years of age or older
• You are already being treated with insulin allowed for study participation.
• Your blood glucose levels are within allowed limits for study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 581
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

• You have had more than 1 emergency treatment for very low blood glucose or poor blood glucose control in the last 6 months.
• You are taking certain diabetes medications that are not allowed for study participation.
• You have major problems with your heart, kidneys, liver, or you have a blood disorder.
• You have had, or are now being treated for, certain types of cancer.

Study & Design

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