pk/pd biosimilarity study of gan & lee insulin glargine injection vs.us & eu lantus® in type 1 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 1

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 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)


Eligibility criteria:
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

Keywords: diabetes diabetes type 1 type 1 basal insulin glargine t1dm diabetes mellitus insulin dependent diabetes