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OpenTrials
Completed

NCT Number: NCT04161976

A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of T1DM for at least 1 year
  • Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
  • Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
  • Participants should have a glycated hemoglobin of ≤9.0% at screening

Exclusion criteria

Treatment and study plan

LY900027

Drug

LY900027 administered to participants with T1DM using CSII.

Insulin Lispro

Drug

Insulin lispro administered to participants with T1DM using CSII.

Other names: Humalog, LY275585

Primary outcomes

  1. Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)

    Time frame: Day 1 through Day 10 in each dosing period

    PK: AUC after Bolus Administration Prior to a MMTT

  2. PK: Maximum Observed Insulin Lispro Concentration (Cmax)

    Time frame: Day 1 through Day 10 in each dosing period

    PK: C PK: Cmax

Secondary outcomes

  1. Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

    Time frame: Day 1 through Day 10 in each dosing period

    PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion

  2. PD: Total Daily Insulin Dose

    Time frame: Day 1 through Day 10 in each dosing period

    PD: Total Daily Insulin Dose

  3. Duration Until Catheter Failure

    Time frame: Day -1 through Day 10 in each dosing period

    Duration Until Catheter Failure

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 LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Aug 5, 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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