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Completed

NCT Number: NCT03056456

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

This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks for each participant.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY900014

Drug

Administered subcutaneously (SC)

Other names: Ultra-Rapid Lispro

Insulin Lispro (Humalog)

Drug

Administered SC

Other names: LY275585, Humalog

Primary outcomes

  1. 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

    PK: Insulin Lispro AUC(0-5h)

  2. 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

    PK: Insulin Lispro AUC(0-5h)

Secondary outcomes

  1. 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

    GD: Change from baseline in AUC (0-5h) of glucose relative to mixed meal tolerance test (MMTT).

  2. 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

    GD: Change from baseline in AUC (0-5h) of glucose relative to MMTT.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2017
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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