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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GZR4 Injection; Drug: Insulin Degludec

• Registration Number: NCT06202079
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-11
• Primary Completion: 2024-07-13
• Study Completion: 2024-08-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GZR4 Injection	GZR4 Injection	GZR4 Injection + Oral Antidiabetic Drug
Insulin Degludec	Insulin Degludec	Insulin Degludec + Oral Antidiabetic Drug

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	From baseline (week 0) to week 16	Change from baseline in HbA1c after 16 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Weekly doses of GZR4 Injection/Insulin Degludec	Week 15-16	Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented.
Incidence and Rate of Treatment-emergent adverse events (TEAEs)	From baseline (week 0) to week 20	A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
Change in ADA of GZR4	From baseline (week 0) to week 16	Blood samples will be analysed for anti-GZR4 antibodies
Change in Nab of GZR4	From baseline (week 0) to week 16	Blood samples will be analysed for Nab
Change in fasting plasma glucose(FPG)	From baseline (week 0) to week 16	Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Incidence and Rate of hypoglycemia episodes	From baseline (week 0) to week 20	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 blood glucose (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.

Trial Locations

Locations (8)

Study Site 01; 🇨🇳 Tianjin, China

Study Site 02; 🇨🇳 Beijing, China

Study Site 05; 🇨🇳 Beijing, China

Study Site 04; 🇨🇳 Zibo, Shandong, China

Study Site 06; 🇨🇳 Changzhou, Jiangsu, China

Study Site 07; 🇨🇳 Wuhan, Hubei, China

Study Site 08; 🇨🇳 Jinan, Shandong, China

Study Site 03; 🇨🇳 Xi'an, Shanxi, China