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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
Profil Mainz GmbH & Co. KG
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
PK endpoint
AUCins. 0 - 24h, area under the serum insulin concentration curve from 0 to 24. hours
Time frame: Up to 24 hours
PK endpoint
Cins.max, maximum observed insulin concentration.
Time frame: Up to 30 hrs
PD endpoint
AUC GIR.0-24h, area under the glucose infusion rate curve from 0 to 24 hours.
Time frame: Up to 24 hours
PD endpoint
GIR max, maximum observed glucose infusion rate
Time frame: Up to 30 hrs
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
Time frame: Up to 24 hrs
Secondary PK endpoint
tmax.ins, time to maximum observed serum insulin concentration
Time frame: Up to 30 hrs
Exploratory PK endpoint
t½, terminal serum elimination half-life calculated as t½=ln2/λz and
Time frame: Up to 30 hrs
Exploratory PK endpoint
λz, terminal elimination rate constant
Time frame: Up to 30 hrs
Secondary PD endpoint
AUC GIR.0 - 12h, AUC GIR.12 - 24h, areas under the glucose infusion rate curve in the indicated time-intervals
Time frame: Up to 24 hrs
Secondary PD endpoint
AUC GIR.0 - last, area under the glucose infusion rate curve from 0 hours until the end of clamp
Time frame: Up to 30 hrs
Secondary PD endpoint
t max.GIR, time to maximum glucose infusion rate
Time frame: Up to 30 hrs
Exploratory PD endpoint
Duration of action, time until blood glucose levels is consistently above 150 mg/dL
Time frame: Up to 30 hrs
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.
Time frame: Up to 30 hrs
Safety endpoints
As measured by treatment-emergent adverse events
Time frame: Up to 12 Weeks
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