A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects With T2DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2 Clinical Trial Comparing the Efficacy and Safety of Once-weekly GZR4 Injection Versus Once-daily Insulin Degludec in Subjects With Type 2 Diabetes Mellitus on OAD Therapy or OAD Therapy in Combination With Basal Insulin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202079
• Other study ID #: GL-GZR-CH2007
• Status: Recruiting
• Phase: Phase 2
• Start date: August 29, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: Gan and Lee Pharmaceuticals, USA
• Contact: Chunyue Hao, PhD
• Phone: 0086-10-56456726
• Email: chunyue.hao[@]ganlee.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18-75 years (both inclusive) at the time of signing ICF

2. Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)

3. Diagnosed with type 2 diabetes mellitus above or equal to 6 months

4. 7.5% = HbA1c = 10.0% at screening.

Exclusion Criteria:

1. Female who is pregnant, breast-feeding.

2. Presence or history of malignant neoplasm prior to screening.

3. Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.

4. Known or suspected hypersensitivity to investigational medical product(s) or related products.

5. Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening

6. 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.

7. Participation in a clinical study of another study drug within 3 month prior to randomization.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GZR4 Injection
GZR4 injection s.c., once-weekly, treat-to-target dose
• Insulin Degludec
Insulin Degludec s.c., once-daily, treat-to-target dose

Locations

Country	Name	City	State
China	Study Site 02	Beijing
China	Study Site 05	Beijing
China	Study Site 06	Changzhou	Jiangsu
China	Study Site 08	Jinan	Shandong
China	Study Site 01	Tianjin
China	Study Site 07	Wuhan	Hubei
China	Study Site 03	Xi'an	Shaanxi
China	Study Site 04	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Gan and Lee Pharmaceuticals, USA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change from baseline in HbA1c after 16 weeks of treatment	From baseline (week 0) to week 16
Secondary	Change in fasting plasma glucose(FPG)	Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment	From baseline (week 0) to week 16
Secondary	Weekly doses of GZR4 Injection/Insulin Degludec	Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented.	Week 15-16
Secondary	Incidence and Rate of Treatment-emergent adverse events (TEAEs)	A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.	From baseline (week 0) to week 20
Secondary	Incidence and Rate of hypoglycemia Events	Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery.	From baseline (week 0) to week 20
Secondary	Change in ADA and Nab of GZR4	Blood samples will be analysed for anti-GZR4 antibodies	From baseline (week 0) to week 16