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

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)

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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