PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Gan & Lee Insulin Aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes, Insulin, Diabetes Mellitus, Basal, Bolus
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
- Healthy male subjects
- Age between 18 and 64 years, both inclusive
- Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
- Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator
Exclusion Criteria:
- Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
- Previous participation in this trial. Participation is defined as randomized
- Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
- Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
- A positive result in the alcohol and/or urine drug screen at the screening visit
- Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- Blood donation or blood loss of m ore than 500 mL within the last 3 months
Sites / Locations
- Profil Mainz GmbH & Co. KG
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Gan & Lee Insulin Aspart
NovoRapid® Insulin Aspart
NovoLog® Insulin Aspart
Arm Description
100 units/mL, 3 ml prefilled pen
Product approved and marketed in the EU FlexPen100 units/mL prefilled pen
Product approved and marketed in the US FlexPen100 units/mL prefilled pen
Outcomes
Primary Outcome Measures
AUCins.0-12h
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Cins.max
PK endpoint: The maximum observed insulin concentration
AUCGIR.0-12h
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
GIRmax
PD endpoint: The maximum glucose infusion rate
Secondary Outcome Measures
AUCins.0-2h
PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
AUCins.0-∞
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
tins.max
PK endpoint: The time to maximum observed insulin concentration
t50%-ins(early)
PK endpoint: The time to half-maximum insulin concentration before Cins.max
t50%-ins(late)
PK endpoint: The time to half-maximum insulin concentration after Cins.max
t½
PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
λz
PK endpoint: The terminal elimination rate constant of insulin
AUCGIR.0-2h
PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
tGIR.max
PD endpoint: The time to maximum glucose infusion rate
tGIR.50%-early
PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
tGIR.50%-late
PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
PD endpoint
time to onset of action
Safety and local tolerability
Number of participants experiencing treatment-emergent adverse events
Full Information
NCT ID
NCT04237129
First Posted
January 15, 2020
Last Updated
February 11, 2020
Sponsor
Gan and Lee Pharmaceuticals, USA
1. Study Identification
Unique Protocol Identification Number
NCT04237129
Brief Title
PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Official Title
A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gan and Lee Pharmaceuticals, USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin aspart preparations
To evaluate the single dose safety and local tolerability of the three insulin aspart preparations
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes, Insulin, Diabetes Mellitus, Basal, Bolus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gan & Lee Insulin Aspart
Arm Type
Experimental
Arm Description
100 units/mL, 3 ml prefilled pen
Arm Title
NovoRapid® Insulin Aspart
Arm Type
Active Comparator
Arm Description
Product approved and marketed in the EU
FlexPen100 units/mL prefilled pen
Arm Title
NovoLog® Insulin Aspart
Arm Type
Active Comparator
Arm Description
Product approved and marketed in the US
FlexPen100 units/mL prefilled pen
Intervention Type
Drug
Intervention Name(s)
Gan & Lee Insulin Aspart
Other Intervention Name(s)
NovoRapid® EU, NovoLog® US
Intervention Description
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.
Primary Outcome Measure Information:
Title
AUCins.0-12h
Description
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Time Frame
0 -12 hours
Title
Cins.max
Description
PK endpoint: The maximum observed insulin concentration
Time Frame
0 -12 hours
Title
AUCGIR.0-12h
Description
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
Time Frame
0 - 12 hours
Title
GIRmax
Description
PD endpoint: The maximum glucose infusion rate
Time Frame
0 - 12 hours
Secondary Outcome Measure Information:
Title
AUCins.0-2h
Description
PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
Time Frame
0 - 2 hours
Title
AUCins.0-∞
Description
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Time Frame
0 - 12 hours
Title
tins.max
Description
PK endpoint: The time to maximum observed insulin concentration
Time Frame
Up to Day 68
Title
t50%-ins(early)
Description
PK endpoint: The time to half-maximum insulin concentration before Cins.max
Time Frame
Up to Day 68
Title
t50%-ins(late)
Description
PK endpoint: The time to half-maximum insulin concentration after Cins.max
Time Frame
Up to Day 68
Title
t½
Description
PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
Time Frame
Up to Day 68
Title
λz
Description
PK endpoint: The terminal elimination rate constant of insulin
Time Frame
Up to Day 68
Title
AUCGIR.0-2h
Description
PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
Time Frame
0 - 2 hours
Title
tGIR.max
Description
PD endpoint: The time to maximum glucose infusion rate
Time Frame
Up to Day 68
Title
tGIR.50%-early
Description
PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
Time Frame
Up to Day 68
Title
tGIR.50%-late
Description
PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
Time Frame
Up to Day 68
Title
PD endpoint
Description
time to onset of action
Time Frame
Up to Day 68
Title
Safety and local tolerability
Description
Number of participants experiencing treatment-emergent adverse events
Time Frame
Up to Day 68
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
Healthy male subjects
Age between 18 and 64 years, both inclusive
Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening
Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator
Exclusion Criteria:
Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
Previous participation in this trial. Participation is defined as randomized
Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
A positive result in the alcohol and/or urine drug screen at the screening visit
Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
Blood donation or blood loss of m ore than 500 mL within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew E Barton, PhD
Organizational Affiliation
Gan & Lee Pharmaceuticals USA Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Profil Mainz GmbH & Co. KG
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
D-55116
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
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