This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
GZR33 is a long-acting basal insulin analogue
Profil Institut
Neuss, Germany
RECRUITINGProfil
Neuss, Germany
RECRUITINGthe relative potency of GZR33 to insulin degludec
Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation: Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33).
Time frame: a two week run-in phase
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