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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04276207
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: LY900014 Drug: Insulin Lispro Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : August 13, 2020
Estimated Study Completion Date : August 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY900014
LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.
Drug: LY900014
Administered by CSII

Active Comparator: Insulin Lispro (Humalog)
Insulin lispro (Humalog) administered by CSII in one of two study periods.
Drug: Insulin Lispro
Administered by CSII
Other Names:
  • Humalog
  • LY275585




Primary Outcome Measures :
  1. Time to Recovery from Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) [ Time Frame: Day 1: Baseline up to 5 hours after missed meal bolus ]
    Time to recovery from hyperglycemia following administration of LY900014 and insulin lispro (Humalog)

  2. Time to Recovery from Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) [ Time Frame: Day 2: Baseline up to 5 hours after pump suspension ]
    Time to recovery from hyperglycemia following administration of LY900014 and insulin lispro (Humalog)


Secondary Outcome Measures :
  1. Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) by Day [ 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) by day

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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276207


Contacts
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Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Germany
Profil Mainz GmbH & Co. KG Recruiting
Mainz, Rheinland-Pfalz, Germany, 55116
Contact    4961312162600      
Principal Investigator: Leona Plum-Mörschel         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04276207    
Other Study ID Numbers: 17277
I8B-MC-ITST ( Other Identifier: Eli Lilly and Company )
2019-003493-13 ( EudraCT Number )
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs