Compares GZR33 insulin with insulin degludec in type 1 diabetes
Tests the insulin GZR33 against insulin degludec in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
Key facts
- Where
- Neuss, GermanySee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07242664, who can take part
Where in Germany
- ProfilNeuss, GermanyTaking people
- Profil InstitutNeuss, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gan and Lee Pharmaceuticals, USA
- Trial code
- NCT07242664
- Record updated
- 21 November 2025
- Original description
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.Read full original descriptionShow less
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: 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: clinically significant concomitant diseases; recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening); estimated glomerular filtration rate (eGFR) <60.0 mL/min/1.73 m2; blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic); hypoglycemia unawareness.