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Trial record 40 of 1486 for:    Type 1 Diabetes Mellitus 5

A Study of LY900014 in Japanese 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: NCT03407118
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.

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 : 40 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 (Humalog) Following Single Dose Administration in Japanese Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : February 17, 2018
Actual Primary Completion Date : June 23, 2018
Actual Study Completion Date : July 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 administered subcutaneously (SC) in one of two study periods.
Drug: LY900014
Administered SC.

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




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Pharmacokinetics: Area Under the Plasma Concentration Curve (AUC) of Insulin Lispro for Each Treatment Arm [ Time Frame: Predose through 10 hours post dose in each period ]
    PK: 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 post dose in each period ]
    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 Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening
  • Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²)
  • Have a glycated hemoglobin <9.0% at screening

Exclusion Criteria:

  • Have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening
  • Have a history of renal impairment (exclusion only if estimated glomerular filtration rate [GFR] <60 milliliters/minute/1.73 square meters [GFR is estimated according to a formula recommended by the Japanese Society of Nephrology]), or have a serum creatinine level ≥126 micromoles per liter (μmol/L) (>1.42 milligrams per deciliter [mg/dL]) (male) or ≥111 μmol/L (>1.25 mg/dL) (female)
  • Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator
  • Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
  • Have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator
  • Require daily insulin treatment >1.5 units per kilogram (U/kg)

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): NCT03407118


Locations
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Japan
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.
Fukuoka, Japan, 812-0025
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: NCT03407118     History of Changes
Other Study ID Numbers: 16645
I8B-MC-ITRZ ( Other Identifier: Eli Lilly and Company )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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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