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Trial record 1 of 1 for:    NCT02623478
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A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

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ClinicalTrials.gov Identifier: NCT02623478
Recruitment Status : Withdrawn (Change in clinical strategy)
First Posted : December 7, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin Lispro - Test Formulation
Novel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods
 Drug: Insulin Lispro
Administered subcutaneously (SC)
Other Name: Humalog
Active Comparator: Insulin Lispro - Reference Formulation
Marketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods
 Drug: Insulin Lispro
Administered subcutaneously (SC)
Other Name: Humalog


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro [ Time Frame: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period ]
    PK: AUC of Insulin Lispro


Secondary Outcome Measures :
  1. Pharmacodynamics (PD): AUC of Glucose Following a Meal [ Time Frame: Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period ]
    PD: AUC of Glucose Following a Meal


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
  • Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
  • Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
  • Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
  • Have venous access sufficient to allow for blood sampling
  • Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

  • Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study
  • Had blood loss of more than 500 milliliters (mL) within the last month
Contacts and Locations
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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): NCT02623478


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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02623478    
Other Study ID Numbers: 15639
F3Z-FW-ITCD ( Other Identifier: Eli Lilly and Company )
2015-003353-18 ( EudraCT Number )
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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 Lispro
Hypoglycemic Agents
Physiological Effects of Drugs