A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03056456
• Date of registration: 15/02/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump
• Scientific title: A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
• Date of first enrolment: February 23, 2017
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03056456
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving
insulin therapy via an approved insulin pump

- Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per
meter squared (kg/m²), inclusive

- Have medical and laboratory test results that are acceptable for the study

- Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a
second party) in the past 6 months

- Have venous access sufficient to allow for blood sampling

- Have provided written consent and are willing to follow study procedures and commit to
the study duration

Exclusion Criteria:

- Are currently participating or recently participated in a clinical trial or any other
type of medical research judged to be incompatible with this study

- Had blood loss of more than 500 milliliters (mL) within the last month

- Have known allergies to LY900014, insulin lispro, related compounds or any components
in the study drug formulations

- Have previously participated or withdrawn from this study

- Have or used to have health problems or medical test results that, in the opinion of
the doctor, could make it unsafe to participate, or could interfere with understanding
the results of the study



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: LY900014

Drug: Insulin Lispro (Humalog)

Primary Outcome(s)

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours(h) (AUC [0-5 h]) Following Administration of Each Study Arm With a Standard Single-wave Bolus [Time Frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose]

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Following Administration of Each Study Arm With a Standard Dual-wave Bolus [Time Frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes post dose]

Secondary Outcome(s)

Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5 h]) of Glucose Relative to MMTT Following Administration of Each Study Arm With a Standard Dual-wave Bolus [Time Frame: Day 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose]

Glucodynamics (GD): Change From Baseline Area Under the Concentration Curve From Time Zero to 5 Hours (AUC [0-5h]) of Glucose Relative to Mixed Meal Tolerance Test Following Administration of Each Study Arm With a Standard Single-wave Bolus [Time Frame: Days 1 and 3: -30, -15, 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180,195, 210, 225, 240, and 300 minutes post dose]

Secondary ID(s)

16727

2016-004093-18

I8B-MC-ITSC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03056456