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

November 17, 2025 updated by: Gan and Lee Pharmaceuticals, USA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Neuss, Germany
      • Neuss, Germany, 41460
        • Recruiting
        • Profil Institut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: GZR-33
GZR33 is a long-acting basal insulin analogue
Experimental: 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
Drug: GZR-33
GZR33 is a long-acting basal insulin analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the relative potency of GZR33 to insulin degludec
Time Frame: a two week run-in phase

Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation:

Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33).
a two week run-in phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan and Lee Pharmaceuticals, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

April 15, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • GZR33-T1D-US101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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