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Diabetes Mellitus, Type 1Phase 1NCT04236895

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

A Phase 1 study testing Gan & Lee Insulin Glargine Injection in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 2 sites 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 objectives: To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins. max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes To demonstrate biosimilarity with regard to the total and… Read more about this study

Who is it for?
Ages 18 to 64 years, men only
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Gan & Lee Insulin Glargine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
2 sitesGermany
Study dates
10 Jul 2018to 28 Nov 2018
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
  • No healthy volunteers
  • 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 performed during normal management of the subject).
  • Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically.
  • Age between 18 and 64 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive.
  • HbA1c <= 9.0%.
  • Fasting negative C-peptide (<= 0.30 nmol/L).
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  • Total insulin dose of < 1.2 (I)U/kg/day.
  • Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).
  • Considered generally healthy (apart from type 1 diabetes mellitus) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator

Who cannot join

  • Known or suspected hypersensitivity to IMPs or related products
  • Previous participation in this trial. Participation is defined as randomized
  • Receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) 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 (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator
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  • Proliferative retinopathy or maculopathy (based on a recent (<1.5 years) ophthalmologic examination) and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
  • Recurrent severe hypoglycemia (more than 1 severe hypoglycemic event during the past 6 months) or hypoglycemic unawareness 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
  • Symptomatic hypotension or supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-140 mmHg for systolic or greater than 90 mmHg for diastolic pressure
  • Heart rate at rest outside the range of 50-90 beats per minute
  • Clinically significant abnormal standard 12-lead ECG after 5 minutes resting in supine position at screening, as judged by the Investigator
  • A positive result in the alcohol and/or urine drug screen at the screening visit
  • Not able or willing to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
  • 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
  • Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of occasional use of Paracetamol or NSAIDs
  • Blood donation or blood loss of more than 500 mL within the last 3 months
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Fertile male with female partner(s) without using a highly effective contraceptive method in combination with spermicide-coated condoms from the first dosing until 1 month after dosing

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Profil Mainz GmbH & Co. KG

    Mainz, 55116

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus

Primary objectives:

To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.

Read more

max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes

Secondary objectives:

To compare the pharmacokinetic and pharmacodynamic properties of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

To assess the safety and tolerability of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

Being tested
Gan & Lee Insulin Glargine Injection
Keywords
Diabetes, Diabetes Type 1, Type 1, Basal, Insulin, Glargine, T1DM, Diabetes Mellitus, Insulin Dependent Diabetes
Medical subject headings
Diabetes Mellitus, Type 1, 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 Glargine InjectionDrug

    All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.

Study groups in NCT04236895
Study groupRoleWhat they receive
Lantus ® USActive comparatorInsulin glargine (Lantus®, product approved and marketed in the USA (US RLD)), 100 U/mL in 3 mL pre-filled pens
Receives: Drug: Gan & Lee Insulin Glargine Injection
Lantus ® EUActive comparatorInsulin glargine (Lantus®, product marketed in Germany (EU RP)), 100 U/mL in 3 ml pre-filled pens
Receives: Drug: Gan & Lee Insulin Glargine Injection
Gan & Lee Insulin GlargineExperimentalInsulin glargine 100 U/mL in 3 mL pre-filled pens
Receives: Drug: Gan & Lee Insulin Glargine Injection

What is being measured

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

  1. PK endpoint

    AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours

    Measured: Up to 24 hours

  2. PK endpoint

    Cins.max, maximum observed insulin concentration.

    Measured: Up to 30 hrs

  3. PD endpoint

    AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours.

    Measured: Up to 24 hours

  4. PD endpoint

    GIR max, maximum observed glucose infusion rate

    Measured: Up to 30 hrs

Secondary outcomes (10)

  1. Secondary PK endpoint

    AUC ins.0-12h, AUC ins.12 - 24h, AUC ins.0 -inf., areas under the serum insulin concentration curve in the indicated time intervals

    Measured: Up to 24 hrs

  2. Secondary PK endpoint

    tmax.ins, time to maximum observed serum insulin concentration

    Measured: Up to 30 hrs

  3. Exploratory PK endpoint

    t½, terminal serum elimination half-life calculated as t½=ln2/λz and

    Measured: Up to 30 hrs

  4. Exploratory PK endpoint

    λz, terminal elimination rate constant

    Measured: Up to 30 hrs

  5. Secondary PD endpoint

    AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals

    Measured: Up to 24 hrs

  6. Secondary PD endpoint

    AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp

    Measured: Up to 30 hrs

  7. Secondary PD endpoint

    t max.GIR, time to maximum glucose infusion rate

    Measured: Up to 30 hrs

  8. Exploratory PD endpoint

    Duration of action, time until blood glucose levels is consistently above 150 mg/dL

    Measured: Up to 30 hrs

  9. Exploratory PD endpoint

    Time to onset of action, time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from - 6 to - 2 minutes before trial product administration as measured by ClampArt.

    Measured: Up to 30 hrs

  10. Safety endpoints

    As measured by treatment-emergent adverse events

    Measured: Up to 12 Weeks

Timeline

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

  1. First posted22 Jan 2020
  2. Study start10 Jul 2018
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 2018

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
The trial will be a randomized, double-blind, multicenter, single-dose, 3-way crossover, 3-treatment, euglycemic glucose clamp trial in male subjects with type 1 diabetes mellitus
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236895
Sponsor's protocol ID
GL-GLA-CT1002
Status last verified
Jan 2020
First submitted
15 Jan 2020
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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 Glargine Injection in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 2 sites 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 9 inclusion and 20 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

PK endpoint (time frame: Up to 24 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 NCT04236895, 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 22 Jan 2020.

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