A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: LY900014; Drug: Insulin Lispro

• Registration Number: NCT03166124
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study Start: 2017-05-24
• Study First Posted: 2017-05-24
• Primary Completion: 2017-11-18
• Study Completion: 2017-11-18
• Status Verified: 2017-12
• Results First Submitted: 2020-04-20
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
• Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)
• Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
• Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria

• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• Have a history of renal impairment
• Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
• Have proliferative retinopathy or maculopathy and/or severe neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Younger Adults LY900014	LY900014	Single, SC 15-U dose of LY900014 in the younger adult group.
Elderly Adults LY900014	LY900014	Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.
Elderly Adults Insulin Lispro	Insulin Lispro	Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.
Younger Adults Insulin Lispro	Insulin Lispro	Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm	Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose	Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose \[AUC(0-10h)\] for each treatment arm.

Secondary Outcome Measures

Name	Time	Method
Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm	Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose	Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇩🇪 Neuss, Germany