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Diabetes MellitusPhase 1NCT04235439

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

A Phase 1 study testing Gan & Lee Insulin Lispro Injection in people with Diabetes Mellitus, run by Gan and Lee Pharmaceuticals, USA at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Gan & Lee Insulin Lispro Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteGermany
Study dates
23 Apr 2019to 3 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Known or suspected hypersensitivity to IMP(s) or related product
  • Previous participation in this trial. Participation is defined as randomized
  • Receipt of any medicinal product in clinical development within 30 days before randomization in this trial
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  • Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
  • Any history or presence of clinically relevant comorbidity, as judged by the Investigator
Show all 27Show fewer
  • Signs of acute illness as judged by the Investigator
  • Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator
  • Clinically significant abnormal screening laboratory tests, as judged by the Investigator
  • 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)
  • Elevation of serum creatinine > ULN, or elevation of serum urea > 10% above ULN
  • 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)
  • Symptoms of arterial hypotension
  • Heart rate at rest outside the range of 50-90 beats per minute
  • Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, 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
  • Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day (on average)
  • A positive result in the alcohol and/or urine drug screen at the screening visit
  • Smoking more than 5 cigarettes or the equivalent per day
  • Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
  • Positive test for Hepatitis Bs antigen
  • 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)
  • Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
  • Any medication (prescription and non-prescription drugs) within 7 days before IMP administration and/or anticoagulant therapy
  • Blood donation or blood loss of more than 500mL within the last 3 months
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Mainz GmbH & Co. KG

    Mainz, 55116

Other trials in Germany

About this study

Official title: 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

Being tested
Gan & Lee Insulin Lispro Injection
Keywords
Diabetes, Insulin, Lispro, Diabetes Mellitus, Basal, Bolus
Medical subject headings
Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gan & Lee Insulin Lispro InjectionDrug

    Also called EU - approved Humalog ®, US - licensed Humalog ®

    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.

Study groups in NCT04235439
Study groupRoleWhat they receive
Gan & Lee Insulin Lispro InjectionExperimentalInsulin lispro, 3 mL cartridge in prefilled pen, 100 units/mL (U-100)
Receives: Drug: Gan & Lee Insulin Lispro Injection
EU - approved Humalog ®Active comparatorInsulin lispro (product approved and marketed in the EU), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
Receives: Drug: Gan & Lee Insulin Lispro Injection
US - licensed Humalog ®Active comparatorInsulin lispro (product approved and marketed in the US), 3 mL cartridge in prefilled Kwikpen®, 100 units/mL (U-100)
Receives: Drug: Gan & Lee Insulin Lispro Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCins.0-12h

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

    Measured: 0 to 12 hours

  2. Cins.max

    PK Endpoint: The maximum observed insulin concentration.

    Measured: 0 to 12 hours

  3. AUCGIR.0-12h

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

    Measured: 0 to 12 hours

  4. GIRmax

    PD endpoint: The maximum glucose infusion rate.

    Measured: 0 to 12 hours

Secondary outcomes (19)

  1. AUCins.0-2h

    PK endpoint: The area under the insulin concentration curve from 0 to 2 hours

    Measured: 0 to 2 hours

  2. AUCins.0-4h

    PK endpoint: The area under the insulin concentration curve from 0 to 4 hours

    Measured: 0 to 4 hours

  3. AUCins.0-6h

    PK endpoint: The area under the insulin concentration curve from 0 to 6 hours

    Measured: 0 to 6 hours

  4. AUCins.6-12h

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

    Measured: 6 to 12 hours

  5. AUCins.0-∞

    PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity

    Measured: 0 to 12 hours

  6. tins.max

    PK endpoint: The time to maximum observed insulin concentration t½, terminal serum elimination half-life calculated as t½=ln2/λz

    Measured: 0 to 12 hours

  7. t50%-ins(early)

    PK endpoint: The time to half-maximum insulin concentration before Cins.max

    Measured: 0 to 12 hours

  8. t50%-ins(late)

    PK endpoint: The time to half-maximum insulin concentration after Cins.max

    Measured: 0 to 12 hours

  9. t½

    PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz

    Measured: 0 to 12 hours

  10. λz

    PK endpoint: The terminal elimination rate constant of insulin

    Measured: 0 to 12 hours

  11. AUCGIR.0-2h

    PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours

    Measured: 0 to 2 hours

  12. AUCGIR.0-4h

    PD endpoint: The area under the glucose infusion rate curve from 0 to 4 hours

    Measured: 0 to 4 hours

  13. AUCGIR.0-6h

    PD endpoint: The area under the glucose infusion rate curve from 0 to 6 hours

    Measured: 0 to 6 hours

  14. AUCGIR.6-12h

    PD endpoint: The area under the glucose infusion rate curve from 6 to 12 hours

    Measured: 6 to 12 hours

  15. tGIR.max

    PD endpoint: The time to maximum glucose infusion rate

    Measured: 0 to 12 hours

  16. tGIR.50%-early

    PD endpoint: The time to half-maximum glucose infusion rate before GIRmax

    Measured: 0 to 12 hours

  17. tGIR.50%-late

    PD endpoint: The time to half-maximum glucose infusion rate after GIRmax

    Measured: 0 to 12 hours

  18. PD endpoint

    time to onset of action

    Measured: 0 to 12 hours

  19. Safety and Local Tolerability

    Number of participants experiencing treatment-emergent adverse events

    Measured: 0 to 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2020
  2. Study start23 Apr 2019
  3. Primary completion3 Jul 2019
  4. Study completion3 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This is a phase 1 trial. The trial is a single center, randomized, doubleblind, single dose, there treatment, three period crossover, 12 - hour euglycaemic glucose clamp trial in healthy male subjects.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235439
Sponsor's protocol ID
GL - LSP - 1006
Status last verified
Jan 2020
First submitted
15 Jan 2020
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37735841

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gan & Lee Insulin Lispro Injection in people with Diabetes Mellitus, run by Gan and Lee Pharmaceuticals, USA at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCins.0-12h (time frame: 0 to 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

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