A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

NCT06202079 | Completed Phase 2

• 1 other identifier: GL-GZR-CH2007
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 8

Brief Summary

This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in HbA1c after 16 weeks of treatment

  From baseline (week 0) to week 16

Secondary Outcomes (6)

• Change in fasting plasma glucose(FPG)

  From baseline (week 0) to week 16

• Weekly doses of GZR4 Injection/Insulin Degludec

  Week 15-16

• Incidence and Rate of Treatment-emergent adverse events (TEAEs)

  From baseline (week 0) to week 20

• Incidence and Rate of hypoglycemia episodes

  From baseline (week 0) to week 20

• Change in ADA of GZR4

  From baseline (week 0) to week 16

Study Arms (2)

GZR4 Injection

EXPERIMENTAL

GZR4 Injection + Oral Antidiabetic Drug

Drug: GZR4 Injection

Insulin Degludec

ACTIVE COMPARATOR

Insulin Degludec + Oral Antidiabetic Drug

Drug: Insulin Degludec

Interventions

GZR4 Injection DRUG

GZR4 injection s.c., once-weekly, treat-to-target dose

GZR4 Injection

Insulin Degludec DRUG

Insulin Degludec s.c., once-daily, treat-to-target dose

Insulin Degludec

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
• Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
• Diagnosed with type 2 diabetes mellitus above or equal to 6 months
• % ≤ HbA1c ≤ 10.0% at screening.

You may not qualify if:

• Female who is pregnant, breast-feeding.
• Presence or history of malignant neoplasm prior to screening.
• Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
• Known or suspected hypersensitivity to investigational medical product(s) or related products.
• Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
• History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
• Participation in a clinical study of another study drug within 3 month prior to randomization.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (8)

Study Site 07

Wuhan, Hubei, China

Location

Study Site 06

Changzhou, Jiangsu, China

Location

Study Site 08

Jinan, Shandong, China

Location

Study Site 04

Zibo, Shandong, China

Location

Study Site 03

Xi’an, Shanxi, China

Location

Study Site 02

Beijing, China

Location

Study Site 05

Beijing, China

Location

Study Site 01

Tianjin, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chunyue Hao

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: August 11, 2023
• Primary Completion: July 13, 2024
• Study Completion: August 8, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)