PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients
Status:
Completed
Trial end date:
2018-11-28
Target enrollment:
Participant gender:
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)