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A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01374178
Recruitment Status : Completed
First Posted : June 15, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: LY2963016 Drug: Lantus Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to Healthy Subjects
Study Start Date : June 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2963016
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
 Drug: LY2963016
Administered subcutaneously
Active Comparator: Lantus
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
 Drug: Lantus
Administered subcutaneously
Other Name: Insulin Glargine


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
    AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.


Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
  2. Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
  3. Total Glucose Infused (Gtot) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
  4. Time of Maximum Glucose Infusion Rate (tRmax) [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]
  5. Number of Participants With Clinically Significant Effects [ Time Frame: Baseline up to 30 days ]
    Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females
  • Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
  • Are nonsmokers
  • Have normal blood pressure and pulse rate
  • Have an electrocardiogram (ECG) considered as within normal limits
  • Have clinical laboratory test results within normal reference range

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
  • Have known allergies to insulin or its excipients
  • Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Show evidence of significant active neuropsychiatric disease
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)
  • Intend to use over-the-counter or prescription medication
  • Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
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): NCT01374178


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
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: NCT01374178    
Other Study ID Numbers: 14094
I4L-MC-ABEI ( Other Identifier: Eli Lilly and Company )
First Posted: June 15, 2011    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs