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

RECRUITINGPhase 1Sponsored by Gan and Lee Pharmaceuticals, USA
Actively Recruiting
PhasePhase 1
SponsorGan and Lee Pharmaceuticals, USA
Started2025-10-13
Est. completion2026-02-28
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07242664

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

Age: 18 Years – 64 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 1 Diabetes Mellitis

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