A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM

A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin

This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: GZR101; Drug: insulin degledec/insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
• BMI = 18.5-35 kg/m2 (inclusive) at screening.
• Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
• 7.0% ≤ HbA1c ≤ 11.0% at screening.

Exclusion Criteria:

• Women in pregnancy or lactation.
• Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
• Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
• Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
• Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
• Known or suspected hypersensitivity to trial product(s).
• Participation in a clinical study of another study drug within 1 month prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR101; GZR101 injection s.c., once daily, treat-to-target dose	Drug: GZR101; Once daily
Active Comparator: insulin degludec/insulin aspart,; insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose	Drug: insulin degledec/insulin aspart; Once daily or twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment	Baseline to week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Plasma Glucose (FPG)	Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment	Baseline to Week 16
The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16	The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented.	Week 16
Incidence and Rate of hypoglycemia Events	Hypoglycaemia alert value (level 1) was defined as episodes that were 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) were defined as episodes that were 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) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery.	Baseline to Week 16
Incidence and Rate of Treatment-emergent AE/SAEs	A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.	Baseline to Week 16
Change from baseline in ADA and Nab	Samples from the GZR101 arm of the study were analysed for anti-drug antibodies.	Baseline to Week 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Body Weight	Change in body weight from baseline to week 16 is presented.	Baseline to Week 16

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Chunyue Hao, PhD, Gan & Lee Pharmaceuticals.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin; Insulin Aspart
• Other Study ID Numbers: GL-GZR-CH2006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No