- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236895
PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients
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.
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Mainz, Germany, 55116
- Profil Mainz GmbH & Co. KG
-
Neuss, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lantus ® US
Insulin glargine (Lantus®, product approved and marketed in the USA (US RLD)), 100 U/mL in 3 mL pre-filled pens
|
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
|
Active Comparator: Lantus ® EU
Insulin glargine (Lantus®, product marketed in Germany (EU RP)), 100 U/mL in 3 ml pre-filled pens
|
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
|
Experimental: Gan & Lee Insulin Glargine
Insulin glargine 100 U/mL in 3 mL pre-filled pens
|
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK endpoint
Time Frame: Up to 24 hours
|
AUCins.
0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours
|
Up to 24 hours
|
PK endpoint
Time Frame: Up to 30 hrs
|
Cins.max, maximum observed insulin concentration.
|
Up to 30 hrs
|
PD endpoint
Time Frame: Up to 24 hours
|
AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours.
|
Up to 24 hours
|
PD endpoint
Time Frame: Up to 30 hrs
|
GIR max, maximum observed glucose infusion rate
|
Up to 30 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary PK endpoint
Time Frame: Up to 24 hrs
|
AUC ins.0-12h,
AUC ins.12 - 24h, AUC ins.0 -inf., areas under the serum insulin concentration curve in the indicated time intervals
|
Up to 24 hrs
|
Secondary PK endpoint
Time Frame: Up to 30 hrs
|
tmax.ins, time to maximum observed serum insulin concentration
|
Up to 30 hrs
|
Exploratory PK endpoint
Time Frame: Up to 30 hrs
|
t½, terminal serum elimination half-life calculated as t½=ln2/λz and
|
Up to 30 hrs
|
Exploratory PK endpoint
Time Frame: Up to 30 hrs
|
λz, terminal elimination rate constant
|
Up to 30 hrs
|
Secondary PD endpoint
Time Frame: Up to 24 hrs
|
AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals
|
Up to 24 hrs
|
Secondary PD endpoint
Time Frame: Up to 30 hrs
|
AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp
|
Up to 30 hrs
|
Secondary PD endpoint
Time Frame: Up to 30 hrs
|
t max.GIR, time to maximum glucose infusion rate
|
Up to 30 hrs
|
Exploratory PD endpoint
Time Frame: Up to 30 hrs
|
Duration of action, time until blood glucose levels is consistently above 150 mg/dL
|
Up to 30 hrs
|
Exploratory PD endpoint
Time Frame: Up to 30 hrs
|
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.
|
Up to 30 hrs
|
Safety endpoints
Time Frame: Up to 12 Weeks
|
As measured by treatment-emergent adverse events
|
Up to 12 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jia Lu, PhD, Gan & Lee Pharmaceuticals, USA
- Principal Investigator: Leona Plum - Mörschel, MD, PD, Profil Mainz GmbH & Co KG
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GL-GLA-CT1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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