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

January 2, 2024 updated by: Gan and Lee Pharmaceuticals, USA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Study site 02
      • Beijing, China
        • Recruiting
        • Study site 05
      • Tianjin, China
        • Recruiting
        • Study site 01
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Study Site 07
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Recruiting
        • Study site 06
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Study site 03
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Study Site 08
      • Zibo, Shandong, China
        • Recruiting
        • Study site 04

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GZR4 Injection
GZR4 Injection + Oral Antidiabetic Drug
Drug: GZR4 Injection
GZR4 injection s.c., once-weekly, treat-to-target dose
Active Comparator: Insulin Degludec
Insulin Degludec + Oral Antidiabetic Drug
Drug: Insulin Degludec
Insulin Degludec s.c., once-daily, treat-to-target dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: From baseline (week 0) to week 16
Change from baseline in HbA1c after 16 weeks of treatment
From baseline (week 0) to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline (week 0) to week 16
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.
Week 15-16
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.
From baseline (week 0) to week 20
Incidence and Rate of hypoglycemia Events
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 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
Change in ADA and Nab of GZR4
Time Frame: From baseline (week 0) to week 16
Blood samples will be analysed for anti-GZR4 antibodies
From baseline (week 0) to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gan and Lee Pharmaceuticals, USA

Investigators

  • Study Director: Clinical Transparency, Gan&Lee Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-GZR-CH2007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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