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A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03465878
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014 Subcutaneous
Single, subcutaneous (SC) dose of LY900014 administered via injection, in one of two study periods
Biological: LY900014
Administered via SC injection

Active Comparator: Insulin Lispro (Humalog) SC
Single, SC dose of insulin lispro (Humalog) administered via injection, in one of two study periods
Biological: Insulin Lispro
Administered via SC injection
Other Names:
  • Humalog
  • LY275585

Experimental: LY900014
Single, SC bolus dose of LY900014 via continuous subcutaneous insulin infusion (CSII) in one of two study periods
Biological: LY900014
Administered via SC injection

Active Comparator: Insulin Lispro (Humalog)
Single, SC bolus dose of insulin lispro (Humalog) via CSII in one of two study periods
Biological: Insulin Lispro
Administered via SC injection
Other Names:
  • Humalog
  • LY275585




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve (AUC) following Each Treatment Arm for Each Study Part [ Time Frame: Baseline through 7 hours post administration of study drug ]
    Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve (AUC) following Each Treatment Arm for Each Study Part


Secondary Outcome Measures :
  1. Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration versus Time Curve Following each Treatment Arm for Each Study Part [ Time Frame: Pre dose through 5 hours post administration of study drug ]
    Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration versus Time Curve Following each Treatment Arm for Each Study Part



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Ages Eligible for Study:   6 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
  • Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria:

  • Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
  • More than one episode of severe hypoglycaemia in the last 6 months
  • Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
  • Have obvious clinical signs or symptoms of liver disease
  • Have a history of renal impairment

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): NCT03465878


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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Canada, Ontario
LMC Endocrinology Centres Ltd. Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact    4166452929      
Principal Investigator: Ronnie Aronson         
Germany
Kinderkrankenhaus auf der Bult Completed
Hannover, Niedersachsen, Germany, 30173
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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03465878     History of Changes
Other Study ID Numbers: 16695
I8B-MC-ITSA ( Other Identifier: Eli Lilly and Company )
2017-003220-78 ( EudraCT Number )
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 15, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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