Type 1 Diabetes Mellitis
Conditions
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.
Interventions
DRUGGZR-33
GZR33 is a long-acting basal insulin analogue
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the relative potency of GZR33 to insulin degludec | 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). |
Countries
Germany
Contacts
Primary ContactAndre Feldmann
Outcome results
None listed