PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Gan & Lee Insulin Aspart
- Registration Number
- NCT04237129
- Lead Sponsor
- Gan and Lee Pharmaceuticals, USA
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gan & Lee Insulin Aspart Gan & Lee Insulin Aspart 100 units/mL, 3 ml prefilled pen NovoLog® Insulin Aspart Gan & Lee Insulin Aspart Product approved and marketed in the US FlexPen100 units/mL prefilled pen NovoRapid® Insulin Aspart Gan & Lee Insulin Aspart Product approved and marketed in the EU FlexPen100 units/mL prefilled pen
- Primary Outcome Measures
Name Time Method AUCins.0-12h 0 -12 hours PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Cins.max 0 -12 hours PK endpoint: The maximum observed insulin concentration
AUCGIR.0-12h 0 - 12 hours PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
GIRmax 0 - 12 hours PD endpoint: The maximum glucose infusion rate
- Secondary Outcome Measures
Name Time Method AUCins.0-2h 0 - 2 hours PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
AUCins.0-∞ 0 - 12 hours PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
tins.max Up to Day 68 PK endpoint: The time to maximum observed insulin concentration
t50%-ins(early) Up to Day 68 PK endpoint: The time to half-maximum insulin concentration before Cins.max
t50%-ins(late) Up to Day 68 PK endpoint: The time to half-maximum insulin concentration after Cins.max
t½ Up to Day 68 PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
λz Up to Day 68 PK endpoint: The terminal elimination rate constant of insulin
AUCGIR.0-2h 0 - 2 hours PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
tGIR.max Up to Day 68 PD endpoint: The time to maximum glucose infusion rate
tGIR.50%-early Up to Day 68 PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
tGIR.50%-late Up to Day 68 PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
PD endpoint Up to Day 68 time to onset of action
Safety and local tolerability Up to Day 68 Number of participants experiencing treatment-emergent adverse events
Trial Locations
- Locations (1)
Profil Mainz GmbH & Co. KG
🇩🇪Mainz, Rhineland-Palatinate, Germany