Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GZR-33.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes Mellitis. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug GZR-33
GZR33 is a long-acting basal insulin analogue
Primary outcome measures
- the relative potency of GZR33 to insulin degludec [Time frame: a two week run-in phase]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Profil Institut — Neuss
- Profil — Neuss
Identifiers
NCT: NCT07242664 · GZR33-T1D-US101