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Trial record 34 of 1486 for:    Type 1 Diabetes Mellitus 5

A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

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ClinicalTrials.gov Identifier: NCT02703324
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study will evaluate a blood sugar lowering insulin, LY900014, 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 LY900014 and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented.

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 : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900014 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods
Drug: LY900014
Administered subcutaneously (SC)

Active Comparator: Insulin Lispro - Reference
Insulin lispro reference formulation 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 SC
Other Name: Humalog, insulin lispro




Primary Outcome Measures :
  1. Pharmacokinetics: 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 ]

Secondary Outcome Measures :
  1. Pharmacodynamics: Area under the Concentration Curve (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 ]


Information from the National Library of Medicine

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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

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): NCT02703324


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.
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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02703324     History of Changes
Other Study ID Numbers: 16070
I8B-FW-ITRF ( Other Identifier: Eli Lilly and Company )
2015‐004705‐16 ( EudraCT Number )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
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