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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01374178
First received: June 13, 2011
Last updated: October 3, 2014
Last verified: October 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: LY2963016
Drug: Lantus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LY2963016 First, Then Lantus A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
Lantus First, Then LY2963016 A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).

Participant Flow for 3 periods

Period 1:   Period 1 (up to 24 Hours After Dosing)
    LY2963016 First, Then Lantus     Lantus First, Then LY2963016  
STARTED     11     5  
Received at Least 1 Dose of LY2963016     11     5  
COMPLETED     11     5  
NOT COMPLETED     0     0  

Period 2:   Washout Period of at Least 7 Days
    LY2963016 First, Then Lantus     Lantus First, Then LY2963016  
STARTED     11     5  
COMPLETED     10     5  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 3:   Period 2 (up to 24 Hours After Dosing)
    LY2963016 First, Then Lantus     Lantus First, Then LY2963016  
STARTED     10     5  
COMPLETED     8     5  
NOT COMPLETED     2     0  
Adverse Event                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Entire Study Population

For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).

For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).


Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  31.1  ± 7.6  
Gender  
[units: participants]
 
Female     3  
Male     13  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     16  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     14  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     2  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Singapore     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)   [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]

2.  Secondary:   Pharmacokinetics: Maximum Concentration (Cmax)   [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]

3.  Secondary:   Maximum Glucose Infusion Rate (Rmax)   [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]

4.  Secondary:   Total Glucose Infused (Gtot)   [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]

5.  Secondary:   Time of Maximum Glucose Infusion Rate (tRmax)   [ Time Frame: Periods 1 and 2: Baseline up to 24 hours ]

6.  Secondary:   Number of Participants With Clinically Significant Effects   [ Time Frame: Baseline up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01374178     History of Changes
Other Study ID Numbers: 14094, I4L-MC-ABEI
Study First Received: June 13, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards