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

August 4, 2020 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Neuss, Nordrhein-Westfalen, Germany, 41460
        • Profil Institut für Stoffwechselforschung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY900027
LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
Drug: LY900027
LY900027 administered to participants with T1DM using CSII.
Active Comparator: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
Drug: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.
Other Names:
  • Humalog
  • LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 through Day 10 in each dosing period
PK: Maximum Observed Insulin Lispro Concentration (Cmax)
Time Frame: Day 1 through Day 10 in each dosing period
PK: C PK: Cmax
Day 1 through Day 10 in each dosing period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 through Day 10 in each dosing period
PD: Total Daily Insulin Dose
Time Frame: Day 1 through Day 10 in each dosing period
PD: Total Daily Insulin Dose
Day 1 through Day 10 in each dosing period
Duration Until Catheter Failure
Time Frame: Day -1 through Day 10 in each dosing period
Duration Until Catheter Failure
Day -1 through Day 10 in each dosing period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2019

Primary Completion (Actual)

July 14, 2020

Study Completion (Actual)

July 14, 2020

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17489 (Registry Identifier: UMCG PaNaMa registry)
  • J2H-MC-IUAA (Other Identifier: Eli Lilly and Company)
  • 2019-002318-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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