A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

April 20, 2020 updated by: Eli Lilly and Company

Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
      • Mainz, Germany
        • 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
        • 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.

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
  • Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)
  • Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
  • Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

  • Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
  • Have a history of renal impairment
  • Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
  • Have proliferative retinopathy or maculopathy and/or severe neuropathy

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Elderly Adults LY900014
Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.
Drug: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
ACTIVE_COMPARATOR: Elderly Adults Insulin Lispro
Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585
EXPERIMENTAL: Younger Adults LY900014
Single, SC 15-U dose of LY900014 in the younger adult group.
Drug: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
ACTIVE_COMPARATOR: Younger Adults Insulin Lispro
Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm
Time Frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm.
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
Time Frame: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose
Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.
Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 24, 2017

Primary Completion (ACTUAL)

November 18, 2017

Study Completion (ACTUAL)

November 18, 2017

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (ACTUAL)

May 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16637
  • I8B-MC-ITRR (OTHER: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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