Actively Recruiting
Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
Led by Gan and Lee Pharmaceuticals, USA · Updated on 2025-11-21
12
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years
- Diagnosed with type 1 diabetes for at least 12 months
- HbA1c less than or equal to 9.0%
- Body Mass Index between 18.5 and 29.0 kg/m2
- On a stable insulin regimen for at least 2 months with dose greater than 0.2 and less than 1.2 U/kg/day
You will not qualify if you...
- Blood pressure outside 90 to 140 mmHg systolic or 50 to 99 mmHg diastolic
- Presence of clinically significant other diseases
- More than one severe hypoglycemic episode requiring assistance within 180 days before screening
- Lack of awareness of hypoglycemia
- Estimated glomerular filtration rate less than 60.0 mL/min/1.73 m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Profil Institut
Neuss, Germany, 41460
Actively Recruiting
2
Profil
Neuss, Germany
Actively Recruiting
Research Team
A
Andre Feldmann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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