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

NCT ID: NCT04237129

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-27
• Study Completion Date: 2019-12-16

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

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gan & Lee Insulin Aspart

100 units/mL, 3 ml prefilled pen

Group Type: EXPERIMENTAL

Gan & Lee Insulin Aspart

Intervention Type: DRUG

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

NovoRapid® Insulin Aspart

Product approved and marketed in the EU

FlexPen100 units/mL prefilled pen

Group Type: ACTIVE_COMPARATOR

Gan & Lee Insulin Aspart

Intervention Type: DRUG

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

NovoLog® Insulin Aspart

Product approved and marketed in the US

FlexPen100 units/mL prefilled pen

Group Type: ACTIVE_COMPARATOR

Gan & Lee Insulin Aspart

Intervention Type: DRUG

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

Interventions

Gan & Lee Insulin Aspart

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.

Intervention Type: DRUG

Other Intervention Names

NovoRapid® EU; NovoLog® US

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew E Barton, PhD

Role: STUDY_DIRECTOR

Gan & Lee Pharmaceuticals USA Corporation

Locations

Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

Chen W, Lu J, Plum-Morschel L, Andersen G, Zijlstra E, He A, Xie T, Li L, Hao C, Gan Z, Heise T. Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin(R)), lispro (prandilin(R)) and glargine (basalin(R)) with EU- und US-sourced reference insulins. Diabetes Obes Metab. 2023 Dec;25(12):3817-3825. doi: 10.1111/dom.15281. Epub 2023 Sep 21.

Reference Type: DERIVED

PMID: 37735841 (View on PubMed)

Other Identifiers

GL-ASP-1008

Identifier Type: -

Identifier Source: org_study_id