PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237129
• Other study ID #: GL-ASP-1008
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: January 2020
• Source: Gan and Lee Pharmaceuticals, USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. 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

2. Healthy male subjects

3. Age between 18 and 64 years, both inclusive

4. Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive

5. Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening

6. 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:

1. Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product

2. Previous participation in this trial. Participation is defined as randomized

3. 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

4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

5. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator

6. 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

7. A positive result in the alcohol and/or urine drug screen at the screening visit

8. 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

9. Blood donation or blood loss of m ore than 500 mL within the last 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Gan & Lee Insulin Aspart
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co. KG	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Gan and Lee Pharmaceuticals, USA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCins.0-12h	PK endpoint: The area under the insulin concentration curve from 0 to 12 hours	0 -12 hours
Primary	Cins.max	PK endpoint: The maximum observed insulin concentration	0 -12 hours
Primary	AUCGIR.0-12h	PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours	0 - 12 hours
Primary	GIRmax	PD endpoint: The maximum glucose infusion rate	0 - 12 hours
Secondary	AUCins.0-2h	PK endpoint: The area under the insulin concentration curve from 0 to 2 hours	0 - 2 hours
Secondary	AUCins.0-8	PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity	0 - 12 hours
Secondary	tins.max	PK endpoint: The time to maximum observed insulin concentration	Up to Day 68
Secondary	t50%-ins(early)	PK endpoint: The time to half-maximum insulin concentration before Cins.max	Up to Day 68
Secondary	t50%-ins(late)	PK endpoint: The time to half-maximum insulin concentration after Cins.max	Up to Day 68
Secondary	t½	PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/?z	Up to Day 68
Secondary	?z	PK endpoint: The terminal elimination rate constant of insulin	Up to Day 68
Secondary	AUCGIR.0-2h	PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours	0 - 2 hours
Secondary	tGIR.max	PD endpoint: The time to maximum glucose infusion rate	Up to Day 68
Secondary	tGIR.50%-early	PD endpoint: The time to half-maximum glucose infusion rate before GIRmax	Up to Day 68
Secondary	tGIR.50%-late	PD endpoint: The time to half-maximum glucose infusion rate after GIRmax	Up to Day 68
Secondary	PD endpoint	time to onset of action	Up to Day 68
Secondary	Safety and local tolerability	Number of participants experiencing treatment-emergent adverse events	Up to Day 68