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Completed

NCT Number: NCT04276207

A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps

The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.

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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 Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, 55116, Germany

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
  • Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
  • Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
  • Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial

Exclusion criteria

  • Known or suspected hypersensitivity to investigational medical product(s) or related products
  • Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
  • Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
  • Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
  • Widespread subcutaneous lipodystrophy in the abdomen
  • Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
  • Chronic or recent use of corticosteroids

Treatment and study plan

LY900014

Drug

Administered by CSII

Insulin Lispro

Drug

Administered by CSII

Other names: Humalog, LY275585

Primary outcomes

  1. Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus

    Time frame: Day 1: Baseline up to 5 hours after missed meal bolus

    Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).

  2. Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension

    Time frame: Day 2: Baseline up to 5 hours after pump suspension

    Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.

Secondary outcomes

  1. Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)

    Time frame: Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension

    PD: PGmax following administration of LY900014 and insulin lispro (Humalog)

  2. Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)

    Time frame: Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension

    PK: Tmax following administration of LY900014 and insulin lispro (Humalog)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Aug 25, 2021

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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