RecruitingRecruiting
Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
NCT07242664 · Gan and Lee Pharmaceuticals, USA
In plain English
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Official title
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
About this study
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
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
Study design
Enrollment target: 12 participants
Allocation: randomized
Masking: double
Age groups: adult
Timeline
Starts: 2025-10-13
Estimated completion: 2026-04-15
Last updated: 2025-11-21
Interventions
Drug: GZR-33
Primary outcomes
- • the relative potency of GZR33 to insulin degludec (a two week run-in phase)
Sponsor
Gan and Lee Pharmaceuticals, USA · industry
Contacts & investigators
ContactAndre Feldmann · contact · 149-1226-GZR-33@profil.com · +49 (0) 2131 4018 409
All locations (2)
Profil InstitutRecruiting
Neuss, Germany
ProfilRecruiting
Neuss, Germany