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

Last updated: August 12, 2024
Sponsor: Gan and Lee Pharmaceuticals, USA
Overall Status: Completed

Phase

1

Condition

Diabetic Gastroparesis

Diabetes Prevention

Diabetic Foot Ulcers

Treatment

Insulin Degludec

GZR4

Clinical Study ID

NCT06553248
GL-GZR-CH1016
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of drug abuse within 1 year before screening, or positive drug abusescreening results during the screening period or at baseline

  • Malignancy or increased risk of malignancy before screening: any suspected and/ordiagnosed malignancy or documented history of malignancy

  • Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, orspecific 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: diabeticketoacidosis, 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 toscreening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1month prior to screening, or recurrent hypoglycaemia-related symptoms

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Insulin Degludec
Phase: 1
Study Start date:
March 22, 2023
Estimated Completion Date:
November 01, 2023

Connect with a study center

  • Gan & Lee Pharmaceuticals Co., Ltd

    Beijing, Beijing 100000
    China

    Site Not Available

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