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

A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared With Insulin Degludec at Steady State in Participants With Type 1 Diabetes

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.

Inclusion Criteria: type 1 diabetes for at least 12 months

• 18-64 years of age
• HbA1c <= 9.0%.
• Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2
• treated with a stable insulin regimen for at least 2 months, in a dose > 0.2 and < 1.2 U/kg/day

Exclusion Criteria:

• 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
• estimated glomerular filtration rate (eGFR) <60.0 mL/min/1.73 m2