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

Gan and Lee Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Type 1 Diabetes Mellitis

Treatments: Drug: GZR-33

Study type: Interventional

Funder types: Industry

Identifiers

NCT07242664

GZR33-T1D-US101

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Period 1 - GZR-33, period 2 insulin degludec

Experimental group

Description:

Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days

Treatment:

Drug: GZR-33

Period 1 - insulin degludec, period 2 - GZR-33

Experimental group

Description:

Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days

Treatment:

Drug: GZR-33