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

Last updated: January 21, 2025
Sponsor: Gan and Lee Pharmaceuticals, USA
Overall Status: Completed

Phase

2

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Insulin Degludec

GZR4 Injection

Clinical Study ID

NCT06202079
GL-GZR-CH2007
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 hyperosmolarsyndrome within 6 months prior to screening.

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

  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 hospitalizationfor coronary heart disease, myocardial infarction, unstable angina, stroke within 6months prior to screening.

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

Study Design

Total Participants: 179
Treatment Group(s): 2
Primary Treatment: Insulin Degludec
Phase: 2
Study Start date:
August 11, 2023
Estimated Completion Date:
August 08, 2024

Connect with a study center

  • Study Site 07

    Wuhan, Hubei
    China

    Site Not Available

  • Study Site 06

    Changzhou, Jiangsu
    China

    Site Not Available

  • Study Site 08

    Jinan, Shandong
    China

    Site Not Available

  • Study Site 04

    Zibo, Shandong
    China

    Site Not Available

  • Study Site 03

    Xi'an, Shanxi
    China

    Site Not Available

  • Study Site 02

    Beijing,
    China

    Site Not Available

  • Study Site 05

    Beijing,
    China

    Site Not Available

  • Study Site 01

    Tianjin,
    China

    Site Not Available

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