Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGan and Lee Pharmaceuticals, USA

About this trial

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.

Eligibility criteria

Qualifiers

18-64 years of age

HbA1c <= 9.0%.

Body Mass Index (BMI) between 18.5 and 29.0 kg/m²

treated with a stable insulin regimen for at least 2 months, in a dose > 0.2 and < 1.2 U/kg/day

Disqualifiers

blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)

clinically significant concomitant diseases

recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)

hypoglycemia unawareness

Trial design

Treatments tested in this trial

  • GZR-33

Treatment groups

12 Participants
are divided into 2 treatment groups