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Completed

NCT Number: NCT06202079

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site 07, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 7.5% ≤ HbA1c ≤ 10.0% at screening.

Exclusion criteria

  • 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.

Treatment and study plan

GZR4 Injection

Drug

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

insulin degludec

Drug

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

Primary outcomes

  1. Change in HbA1c

    Time frame: From baseline (week 0) to week 16

    Change from baseline in HbA1c after 16 weeks of treatment

Secondary outcomes

  1. Change in fasting plasma glucose(FPG)

    Time frame: From baseline (week 0) to week 16

    Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment

  2. Weekly doses of GZR4 Injection/Insulin Degludec

    Time frame: Week 15-16

    Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented.

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

    Time frame: 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.

  4. Incidence and Rate of hypoglycemia episodes

    Time frame: 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.

  5. Change in ADA of GZR4

    Time frame: From baseline (week 0) to week 16

    Blood samples will be analysed for anti-GZR4 antibodies

  6. Change in Nab of GZR4

    Time frame: From baseline (week 0) to week 16

    Blood samples will be analysed for Nab

Sponsors and collaborators

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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