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A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

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: NCT02111083
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:

The study involves 4 injections of insulin lispro and its purpose is to:

  • Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
  • Compare how the 2 formulations of insulin lispro affect blood sugar level.
  • Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Insulin Lispro Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Insulin Lispro A
Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test [T]).
 Biological: Insulin Lispro
LY275585 administered SC.
Experimental: Insulin Lispro B
Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference [R]).
 Biological: Insulin Lispro
LY275585 administered SC.


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast) [ Time Frame: Day 1, predose through 8 hours post dose in each period. ]
  2. Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax) [ Time Frame: Day 1, predose through 8 hours post dose in each period ]
  3. Pharmacokinetic Parameter: Area Under the Curve(AUC) [ Time Frame: Zero to infinity [AUC(0-∞)] ]

Secondary Outcome Measures :
  1. Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax) [ Time Frame: Day 1, predose through 8 hours post dose in each period. ]
  2. Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) [ Time Frame: Day1, predose through 8 hours post dose in each period. ]
    The total amount of glucose infused during the euglycemic clamp procedure.

  3. Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Day 1, predose through 8 hours post dose in each period. ]
    The maximum observed glucose infusion rate during the euglycemic clamp procedure.

  4. Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) [ Time Frame: Day 1, predose through 8 hours post dose in each period. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are healthy males or females
  • Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m^2)
  • Are nonsmokers
  • Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria:

  • History of first-degree relatives known to have diabetes mellitus
  • Evidence of significant active neuropsychiatric disease
  • Evidence of an acute infection with fever or infectious disease
  • Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
  • Have used systemic glucocorticoids within 3 months prior to entry into the study.
  • Have donated blood of 1 unit or more within the last 3 months prior to study entry
  • Excessive alcohol intake
  • Have a fasting venous blood glucose (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
  • Have positive hepatitis B surface antigen.
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): NCT02111083


Locations
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Singapore
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Singapore, Singapore, 117597
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: NCT02111083    
Other Study ID Numbers: 15418
F3Z-EW-IOQM ( Other Identifier: Eli Lilly and Company )
First Posted: April 10, 2014    Key Record Dates
Results First Posted: May 21, 2015
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs