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

NCT04237129 | Completed Phase 1 FDA Drug

• 1 other identifier: GL-ASP-1008
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Diabetes; Insulin; Diabetes Mellitus; Basal; Bolus

Outcome Measures

Primary Outcomes (4)

• AUCins.0-12h

  PK endpoint: The area under the insulin concentration curve from 0 to 12 hours

  0 -12 hours

• Cins.max

  PK endpoint: The maximum observed insulin concentration

  0 -12 hours

• AUCGIR.0-12h

  PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours

  0 - 12 hours

• GIRmax

  PD endpoint: The maximum glucose infusion rate

  0 - 12 hours

Secondary Outcomes (13)

• AUCins.0-2h

  0 - 2 hours

• AUCins.0-∞

  0 - 12 hours

• tins.max

  Up to Day 68

• t50%-ins(early)

  Up to Day 68

• t50%-ins(late)

  Up to Day 68

Study Arms (3)

Gan & Lee Insulin Aspart

EXPERIMENTAL

100 units/mL, 3 ml prefilled pen

Drug: Gan & Lee Insulin Aspart

NovoRapid® Insulin Aspart

ACTIVE COMPARATOR

Product approved and marketed in the EU FlexPen100 units/mL prefilled pen

Drug: Gan & Lee Insulin Aspart

NovoLog® Insulin Aspart

ACTIVE COMPARATOR

Product approved and marketed in the US FlexPen100 units/mL prefilled pen

Drug: Gan & Lee Insulin Aspart

Interventions

Gan & Lee Insulin Aspart DRUG

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

Also known as: NovoRapid® EU, NovoLog® US

Gan & Lee Insulin Aspart; NovoLog® Insulin Aspart; NovoRapid® Insulin Aspart

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Profil Mainz GmbH & Co. KG

Mainz, Rhineland-Palatinate, D-55116, Germany

Location

Related Publications (1)

• 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.

  PMID: 37735841 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

gallium nitrate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Matthew E Barton, PhD

  Gan & Lee Pharmaceuticals USA Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 23, 2020
• Study Start: August 27, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)