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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- the relative potency of GZR33 to insulin degludec
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: GZR-33 (Drug)
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
Intervention: GZR-33 (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported