RecruitingPhase 1NCT07242664
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
Sponsor
Gan and Lee Pharmaceuticals, USA
Enrollment
12 participants
Start Date
Oct 13, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 64 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
DRUGGZR-33
GZR33 is a long-acting basal insulin analogue
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07242664