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

Recruiting Phase 1 Interventional Study
Type 1 Diabetes Mellitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Gan and Lee Pharmaceuticals, USA · Industry
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About This Trial

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.

Trial Locations
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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 …
Contacts

Andre Feldmann

+49 (0) 2131 4018 409

149-1226-GZR-33@profil.com

CONTACT