The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
111
dosage form: Subcutaneous injection
Profil Institute for clinical Research
Chula Vista, California, United States
Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h.
Time frame: over 24hrs post dose
Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs
Time frame: over 24hrs post dose
Pharmacokinetic Parameters: Maximum concentration (Cmax)
Time frame: over 24hrs post dose
Safety parameters
Number of AE's, SAE's, Hypoglycemic events and local tolerability
Time frame: till 24 hrs post-dose
Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs
AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h
Time frame: over 24hrs post dose
Pharmacokinetic parameter: Area under curve from 0-24hrs
AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs
Time frame: over 24hrs post dose
Pharmacokinetic Parameters: tmax and t1/2
Time frame: over 24hrs post dose
Pharmacodynamic parameter: GIR max and tGIR max
Time frame: over 24hrs post dose
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