A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT03341299
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study Start: 2017-11-13
• Study First Posted: 2017-11-14
• Status Verified: 2018-04
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Results First Submitted: 2020-04-20
• Results First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Results First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
• Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
• Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
• Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Exclusion Criteria

• Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
• Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
• Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
• Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
• Are treated with a CSII (insulin pump)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)	Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)	PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

Secondary Outcome Measures

Name	Time	Method
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve	Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose	GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm

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