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

ConditionType 1 Diabetes Mellitis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-64

SponsorGan and Lee Pharmaceuticals, USA

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-64 years of age

HbA1c <= 9.0%.

Body Mass Index (BMI) between 18.5 and 29.0 kg/m²

treated with a stable insulin regimen for at least 2 months, in a dose > 0.2 and < 1.2 U/kg/day

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

GZR-33
Drug
GZR33 is a long-acting basal insulin analogue

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Period 1 - GZR-33, period 2 insulin degludecExperimental treatment 1 intervention

Group B: Period 1 - insulin degludec, period 2 - GZR-33Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

the relative potency of GZR33 to insulin degludec

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).

Time frame

a two week run-in phase

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gan and Lee Pharmaceuticals, USA

Lead sponsor

Source ClinicalTrials.gov

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