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