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A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01476345
Recruitment Status : Completed
First Posted : November 22, 2011
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Diabetes Mellitus
Interventions Drug: LY2963016
Drug: Lantus
Enrollment 80
Recruitment Details  
Pre-assignment Details This was a randomized, 2-sequence, 4-period, crossover study.
Arm/Group Title LY/Lantus/LY/Lantus Lantus/LY/Lantus/LY
Hide Arm/Group Description

Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.

A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.

Minimum washout interval of 7 days between each period.

Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.

A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.

Minimum washout interval of 7 days between each period.

Period Title: Period 1
Started 40 40
Received at Least 1 Dose of Study Drug 40 40
Completed 40 40
Not Completed 0 0
Period Title: Period 2
Started 40 40
Completed 40 [1] 40 [1]
Not Completed 0 0
[1]
1 did not enter Period 3 due to participant's decision.
Period Title: Period 3
Started 39 39
Completed 39 39
Not Completed 0 0
Period Title: Period 4
Started 39 39
Completed 39 39
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
32.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
24
  30.0%
Male
56
  70.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
  12.5%
White
64
  80.0%
More than one race
6
   7.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 80 participants
80
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus
Hide Description [Not Specified]
Time Frame 1 hour predose up to 24 hours postdose in all treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.
Arm/Group Title LY2963016 Lantus
Hide Arm/Group Description:
A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
Overall Number of Participants Analyzed 79 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picomoles*hour/Liter (pmol*h/L)
1810
(40%)
1980
(36%)
2.Primary Outcome
Title Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus
Hide Description [Not Specified]
Time Frame 1 hour predose up to 24 hours postdose in all treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.
Arm/Group Title LY2963016 Lantus
Hide Arm/Group Description:
A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
Overall Number of Participants Analyzed 80 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picomoles/Liter (pmol/L)
112
(39%)
119
(34%)
3.Secondary Outcome
Title Maximum Glucose Infusion Rate (Rmax)
Hide Description Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Time Frame 1 hour predose up to 24 hours postdose in all treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received.
Arm/Group Title LY2963016 Lantus
Hide Arm/Group Description:
A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
Overall Number of Participants Analyzed 80 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams/kilogram/minute (mg/kg/min)
2.85
(46%)
2.88
(41%)
4.Secondary Outcome
Title Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
Hide Description Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Time Frame 1 hour predose up to 24 hours postdose in all treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received.
Arm/Group Title LY2963016 Lantus
Hide Arm/Group Description:
A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
Overall Number of Participants Analyzed 80 80
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams/kilogram (mg/kg)
2580
(45%)
2710
(40%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2963016 Lantus
Hide Arm/Group Description A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence. A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
All-Cause Mortality
LY2963016 Lantus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
LY2963016 Lantus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/80 (0.00%)      0/80 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
LY2963016 Lantus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/80 (62.50%)      54/80 (67.50%)    
Gastrointestinal disorders     
Diarrhoea  1  4/80 (5.00%)  4 1/80 (1.25%)  1
Nausea  1  4/80 (5.00%)  5 5/80 (6.25%)  5
General disorders     
Injection site erythema  1  4/80 (5.00%)  4 2/80 (2.50%)  3
Injection site pain  1  5/80 (6.25%)  5 6/80 (7.50%)  7
Injury, poisoning and procedural complications     
Procedural site reaction  1  17/80 (21.25%)  21 17/80 (21.25%)  23
Nervous system disorders     
Headache  1  15/80 (18.75%)  19 25/80 (31.25%)  27
Reproductive system and breast disorders     
Dysmenorrhoea  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01476345    
Other Study ID Numbers: 13711
I4L-MC-ABEA ( Other Identifier: Eli Lilly and Company )
First Submitted: October 5, 2011
First Posted: November 22, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014