Diabetes Mellitus, Type 1Phase 1NCT04237129
PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
A Phase 1 study testing Gan & Lee Insulin Aspart in people with Diabetes Mellitus, Type 1, run by Gan and Lee Pharmaceuticals, USA at 1 site in Germany.
Trial 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… 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, Type 1
- What is being tested?
- Gan & Lee Insulin Aspart
- 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
- 27 Aug 2019to 16 Dec 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 <= 5.50 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
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
- Being tested
- Gan & Lee Insulin Aspart
- Keywords
- Diabetes, Insulin, Diabetes Mellitus, Basal, Bolus
- 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 AspartDrug
Also called NovoRapid® EU, NovoLog® US
All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.
| Study group | Role | What they receive |
|---|---|---|
| Gan & Lee Insulin Aspart | Experimental | 100 units/mL, 3 ml prefilled pen Receives: Drug: Gan & Lee Insulin Aspart |
| NovoRapid® Insulin Aspart | Active comparator | Product approved and marketed in the EU
FlexPen100 units/mL prefilled pen Receives: Drug: Gan & Lee Insulin Aspart |
| NovoLog® Insulin Aspart | Active comparator | Product approved and marketed in the US
FlexPen100 units/mL prefilled pen Receives: Drug: Gan & Lee Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCins.0-12h
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Measured: 0 -12 hours
Cins.max
PK endpoint: The maximum observed insulin concentration
Measured: 0 -12 hours
AUCGIR.0-12h
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
Measured: 0 - 12 hours
GIRmax
PD endpoint: The maximum glucose infusion rate
Measured: 0 - 12 hours
Secondary outcomes (13)
AUCins.0-2h
PK endpoint: The area under the insulin concentration curve from 0 to 2 hours
Measured: 0 - 2 hours
AUCins.0-∞
PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity
Measured: 0 - 12 hours
tins.max
PK endpoint: The time to maximum observed insulin concentration
Measured: Up to Day 68
t50%-ins(early)
PK endpoint: The time to half-maximum insulin concentration before Cins.max
Measured: Up to Day 68
t50%-ins(late)
PK endpoint: The time to half-maximum insulin concentration after Cins.max
Measured: Up to Day 68
t½
PK endpoint: The terminal serum elimination half-life calculated as t½=ln2/λz
Measured: Up to Day 68
λz
PK endpoint: The terminal elimination rate constant of insulin
Measured: Up to Day 68
AUCGIR.0-2h
PD endpoint: The area under the glucose infusion rate curve from 0 to 2 hours
Measured: 0 - 2 hours
tGIR.max
PD endpoint: The time to maximum glucose infusion rate
Measured: Up to Day 68
tGIR.50%-early
PD endpoint: The time to half-maximum glucose infusion rate before GIRmax
Measured: Up to Day 68
tGIR.50%-late
PD endpoint: The time to half-maximum glucose infusion rate after GIRmax
Measured: Up to Day 68
PD endpoint
time to onset of action
Measured: Up to Day 68
Safety and local tolerability
Number of participants experiencing treatment-emergent adverse events
Measured: Up to Day 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Aug 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew E Barton, PhD, Study director, Gan & Lee Pharmaceuticals USA Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237129
- Sponsor's protocol ID
- GL-ASP-1008
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04237129
- Acronym / sponsor ID
- GL-ASP-1008
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes, Insulin, Diabetes Mellitus, Basal, Bolus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gan & Lee Insulin Aspart | Experimental | Drug: Gan & Lee Insulin Aspart100 units/mL, 3 ml prefilled pen |
| NovoRapid® Insulin Aspart | Active comparator | Drug: Gan & Lee Insulin AspartProduct approved and marketed in the EU FlexPen100 units/mL prefilled pen |
| NovoLog® Insulin Aspart | Active comparator | Drug: Gan & Lee Insulin AspartProduct approved and marketed in the US FlexPen100 units/mL prefilled pen |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gan & Lee Insulin AspartAlso: NovoRapid® EU, NovoLog® USAll three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area. | Drug | Gan & Lee Insulin Aspart, NovoLog® Insulin Aspart, NovoRapid® Insulin Aspart |
Primary outcome
AUCins.0-12h
Time frame: 0 -12 hours
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Cins.max
Time frame: 0 -12 hours
PK endpoint: The maximum observed insulin concentration
AUCGIR.0-12h
Time frame: 0 - 12 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
GIRmax
Time frame: 0 - 12 hours
PD endpoint: The maximum glucose infusion rate
13 secondary outcomes
AUCins.0-2h
Time frame: 0 - 2 hours
AUCins.0-∞
Time frame: 0 - 12 hours
tins.max
Time frame: Up to Day 68
t50%-ins(early)
Time frame: Up to Day 68
t50%-ins(late)
Time frame: Up to Day 68
t½
Time frame: Up to Day 68
λz
Time frame: Up to Day 68
AUCGIR.0-2h
Time frame: 0 - 2 hours
tGIR.max
Time frame: Up to Day 68
tGIR.50%-early
Time frame: Up to Day 68
tGIR.50%-late
Time frame: Up to Day 68
PD endpoint
Time frame: Up to Day 68
Safety and local tolerability
Time frame: Up to Day 68
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 37735841Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew E Barton, PhD study director
Gan & Lee Pharmaceuticals USA Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gan & Lee Insulin Aspart in people with Diabetes Mellitus, Type 1, 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 9 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 -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 NCT04237129, 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.