Diabetes Mellitus, Type 1 Clinical Trial
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
Verified date | January 2020 |
Source | Gan and Lee Pharmaceuticals, USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 114 |
Est. completion date | November 28, 2018 |
Est. primary completion date | November 28, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Mainz GmbH & Co. KG | Mainz | |
Germany | Profil Institut für Stoffwechselforschung GmbH | Neuss |
Lead Sponsor | Collaborator |
---|---|
Gan and Lee Pharmaceuticals, USA |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PK endpoint | AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours | Up to 24 hours | |
Primary | PK endpoint | Cins.max, maximum observed insulin concentration. | Up to 30 hrs | |
Primary | PD endpoint | AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours. | Up to 24 hours | |
Primary | PD endpoint | GIR max, maximum observed glucose infusion rate | Up to 30 hrs | |
Secondary | 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 | Up to 24 hrs | |
Secondary | Secondary PK endpoint | tmax.ins, time to maximum observed serum insulin concentration | Up to 30 hrs | |
Secondary | Exploratory PK endpoint | t½, terminal serum elimination half-life calculated as t½=ln2/?z and | Up to 30 hrs | |
Secondary | Exploratory PK endpoint | ?z, terminal elimination rate constant | Up to 30 hrs | |
Secondary | Secondary PD endpoint | 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 | Secondary PD endpoint | AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp | Up to 30 hrs | |
Secondary | Secondary PD endpoint | t max.GIR, time to maximum glucose infusion rate | Up to 30 hrs | |
Secondary | Exploratory PD endpoint | Duration of action, time until blood glucose levels is consistently above 150 mg/dL | Up to 30 hrs | |
Secondary | 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. | Up to 30 hrs | |
Secondary | Safety endpoints | As measured by treatment-emergent adverse events | Up to 12 Weeks |
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