Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State
NCT ID: NCT07242664
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-10-13
2026-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Period 1 - GZR-33, period 2 insulin degludec
Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days
GZR-33
GZR33 is a long-acting basal insulin analogue
Period 1 - insulin degludec, period 2 - GZR-33
Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days
GZR-33
GZR33 is a long-acting basal insulin analogue
Interventions
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GZR-33
GZR33 is a long-acting basal insulin analogue
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Gan and Lee Pharmaceuticals, USA
INDUSTRY
Responsible Party
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Locations
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Profil Institut
Neuss, , Germany
Profil
Neuss, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GZR33-T1D-US101
Identifier Type: -
Identifier Source: org_study_id
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