ClinicalTrials.Veeva

Menu

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

G

Gan and Lee Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Diabetes

Treatments

Drug: Insulin Degludec
Drug: GZR4

Study type

Interventional

Funder types

Industry

Identifiers

NCT06553248
GL-GZR-CH1016

Details and patient eligibility

About

This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female at the age of 18-65 (inclusive) at the time of informed consent
  • Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
  • Diagnosis of type 2 diabetes mellitus for over 3 months
  • Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.

Exclusion criteria

  • History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
  • Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
  • Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
  • Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
  • Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

GZR4
Experimental group
Description:
s.c., once weekly
Treatment:
Drug: GZR4
Insulin Degludec
Active Comparator group
Description:
s.c., once daily
Treatment:
Drug: Insulin Degludec

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems