A study of LY900014 compared to Humalog in children, adolescents and adults with Type 1 Diabetes Mellitus

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-003220-78-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-26
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year

Glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Have had no episodes of severe hypoglycaemia in the last 6 months

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening

Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency

Have obvious clinical signs or symptoms of liver disease

Have a history of renal impairment

Study & Design

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