PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

February 11, 2020 updated by: Gan and Lee Pharmaceuticals, USA

A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Lispro Injection With Both EU - Approved and US - Licensed Humalog® in Healthy Male Subjects

Primary objective:

To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects

Secondary objectives:

To compare the PK and PD parameters of the three insulin lispro preparations

To evaluate the single dose safety and local tolerability of the three insulin lispro preparations

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Profil Mainz GmbH & Co. KG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 <= 5.5 mmol/L (100 mg/dL) at screening
  6. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator

Exclusion Criteria:

  1. Known or suspected hypersensitivity to IMP(s) or related product
  2. Previous participation in this trial. Participation is defined as randomized
  3. Receipt of any medicinal product in clinical development within 30 days before randomization in this trial
  4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  5. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
  6. Any history or presence of clinically relevant comorbidity, as judged by the Investigator
  7. Signs of acute illness as judged by the Investigator
  8. Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator
  9. Clinically significant abnormal screening laboratory tests, as judged by the Investigator
  10. Elevation of serum ALT> 10% above the ULN, or elevation of serum AST or serum bilirubin >20% above the ULN. (Note: Elevation of bilirubin is considered acceptable in case of Gilbert's disease and should be evaluated in clinical context)
  11. Elevation of serum creatinine > ULN, or elevation of serum urea > 10% above ULN
  12. Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension)
  13. Symptoms of arterial hypotension
  14. Heart rate at rest outside the range of 50-90 beats per minute
  15. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator
  16. 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
  17. Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (on average)
  18. A positive result in the alcohol and/or urine drug screen at the screening visit
  19. Smoking more than 5 cigarettes or the equivalent per day
  20. Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
  21. Positive test for Hepatitis Bs antigen
  22. Positive test for Hepatitis C antibodies. (Presence of Hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative)
  23. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
  24. Any medication (prescription and non-prescription drugs) within 7 days before IMP administration and/or anticoagulant therapy
  25. Blood donation or blood loss of more than 500mL within the last 3 months
  26. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation

Explanatory note on Exclusion Criterion 24: With the exception of paracetamol or NSAIDs for occasional use to treat acute pain, as judged by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gan & Lee Insulin Lispro Injection
Insulin lispro, 3 mL cartridge in prefilled pen, 100 units/mL (U-100)
Drug: Gan & Lee Insulin Lispro Injection
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.
Other Names:
  • EU - approved Humalog ®
  • US - licensed Humalog ®
Active Comparator: EU - approved Humalog ®
Insulin lispro (product approved and marketed in the EU), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
Drug: Gan & Lee Insulin Lispro Injection
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.
Other Names:
  • EU - approved Humalog ®
  • US - licensed Humalog ®
Active Comparator: US - licensed Humalog ®
Insulin lispro (product approved and marketed in the US), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
Drug: Gan & Lee Insulin Lispro Injection
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.
Other Names:
  • EU - approved Humalog ®
  • US - licensed Humalog ®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCins.0-12h
Time Frame: 0 to 12 hours
PK Endpoint: The area under the insulin concentration curve from 0 to 12 hours.
0 to 12 hours
Cins.max
Time Frame: 0 to 12 hours
PK Endpoint: The maximum observed insulin concentration.
0 to 12 hours
AUCGIR.0-12h
Time Frame: 0 to 12 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours.
0 to 12 hours
GIRmax
Time Frame: 0 to 12 hours
PD endpoint: The maximum glucose infusion rate.
0 to 12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUCins.0-2h
Time Frame: 0 to 2 hours
PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
0 to 2 hours
AUCins.0-4h
Time Frame: 0 to 4 hours
PK endpoint: The area under the insulin concentration curve from 0 to 4 hours
0 to 4 hours
AUCins.0-6h
Time Frame: 0 to 6 hours
PK endpoint: The area under the insulin concentration curve from 0 to 6 hours
0 to 6 hours
AUCins.6-12h
Time Frame: 6 to 12 hours
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
6 to 12 hours
AUCins.0-∞
Time Frame: 0 to 12 hours
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
0 to 12 hours
tins.max
Time Frame: 0 to 12 hours
PK endpoint: The time to maximum observed insulin concentration t½, terminal serum elimination half-life calculated as t½=ln2/λz
0 to 12 hours
t50%-ins(early)
Time Frame: 0 to 12 hours
PK endpoint: The time to half-maximum insulin concentration before Cins.max
0 to 12 hours
t50%-ins(late)
Time Frame: 0 to 12 hours
PK endpoint: The time to half-maximum insulin concentration after Cins.max
0 to 12 hours
t½
Time Frame: 0 to 12 hours
PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
0 to 12 hours
λz
Time Frame: 0 to 12 hours
PK endpoint: The terminal elimination rate constant of insulin
0 to 12 hours
AUCGIR.0-2h
Time Frame: 0 to 2 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
0 to 2 hours
AUCGIR.0-4h
Time Frame: 0 to 4 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 4 hours
0 to 4 hours
AUCGIR.0-6h
Time Frame: 0 to 6 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 6 hours
0 to 6 hours
AUCGIR.6-12h
Time Frame: 6 to 12 hours
PD endpoint: The area under the glucose infusion rate curve from 6 to 12 hours
6 to 12 hours
tGIR.max
Time Frame: 0 to 12 hours
PD endpoint: The time to maximum glucose infusion rate
0 to 12 hours
tGIR.50%-early
Time Frame: 0 to 12 hours
PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
0 to 12 hours
tGIR.50%-late
Time Frame: 0 to 12 hours
PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
0 to 12 hours
PD endpoint
Time Frame: 0 to 12 hours
time to onset of action
0 to 12 hours
Safety and Local Tolerability
Time Frame: 0 to 12 hours
Number of participants experiencing treatment-emergent adverse events
0 to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gan and Lee Pharmaceuticals, USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jia Lu, PhD, Gan & Lee Pharmaceuticals, USA
  • Principal Investigator: Leona Plum - Mörschel, Dr. med, Profil Mainz GmbH & Co KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GL - LSP - 1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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