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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 September 2015 |
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Main ID: |
NCT02293551 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Lispro Formulations in Healthy Participants
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Scientific title:
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Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02293551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Overtly healthy males or females (nonchildbearing potential and with absent cyclical
hormonal changes), as determined by medical history and physical examination
Exclusion Criteria:
- Have a fasting plasma glucose less than or equal to (=) 4.0 millimole per liter (mmol/L)
at screening
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Lispro
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Primary Outcome(s)
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Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585
[Time Frame: Predose through day 1 in each period]
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Secondary ID(s)
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F3Z-FW-ITCA
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15626
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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