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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166124
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The purpose of this study is to compare LY900014 with insulin lispro 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.


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)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : November 18, 2017
Actual Study Completion Date : November 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014 (elderly group)
Single, subcutaneous (SC) dose of LY900014 in the elderly group
Drug: LY900014
Administered SC

Experimental: LY900014 (younger adult group)
Single, SC dose of LY900014 in the younger adult group
Drug: LY900014
Administered SC

Active Comparator: Insulin Lispro (younger adult group)
Single, SC dose of insulin lispro in the younger adult group
Drug: Insulin Lispro
Administered SC

Active Comparator: Insulin Lispro (elderly group)
Single, SC dose of insulin lispro in the elderly group
Drug: Insulin Lispro
Administered SC




Primary Outcome Measures :
  1. Pharmacokinetics: Area Under the Plasma Concentration Curve (AUC) of Insulin Lispro for Each Treatment Arm [ Time Frame: Predose through 10 hours postdose in each period ]
    Pharmacokinetics: Area Under the Plasma Concentration Curve (AUC) of Insulin Lispro for Each Treatment Arm


Secondary Outcome Measures :
  1. Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm [ Time Frame: Predose through 10 hours postdose in each period ]
    Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03166124


Locations
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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.
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
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: NCT03166124     History of Changes
Other Study ID Numbers: 16637
I8B-MC-ITRR ( Other Identifier: Eli Lilly and Company )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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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
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs