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Diabetes Mellitus, Type 2Phase 2NCT06202079

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

A Phase 2 study testing GZR4 Injection and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
GZR4 Injection and Insulin Degludec
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
8 sitesChina
Study dates
11 Aug 2023to 8 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Study Site 02

    Beijing

  • Study Site 05

    Beijing

  • Study Site 06

    Changzhou, Jiangsu

  • Study Site 08

    Jinan, Shandong

  • Study Site 01

    Tianjin

  • Study Site 07

    Wuhan, Hubei

  • Study Site 03

    Xi’an, Shanxi

  • Study Site 04

    Zibo, Shandong

Other trials in China

About this study

Official 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

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.

Being tested
GZR4 Injection, Insulin Degludec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GZR4 InjectionDrug

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

  • Insulin DegludecDrug

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

Study groups in NCT06202079
Study groupRoleWhat they receive
GZR4 InjectionExperimentalGZR4 Injection + Oral Antidiabetic Drug
Receives: Drug: GZR4 Injection
Insulin DegludecActive comparatorInsulin Degludec + Oral Antidiabetic Drug
Receives: Drug: Insulin Degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change from baseline in HbA1c after 16 weeks of treatment

    Measured: From baseline (week 0) to week 16

Secondary outcomes (6)

  1. Change in fasting plasma glucose(FPG)

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

    Measured: From baseline (week 0) to week 16

  2. Weekly doses of GZR4 Injection/Insulin Degludec

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

    Measured: Week 15-16

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

    A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.

    Measured: From baseline (week 0) to week 20

  4. Incidence and Rate of hypoglycemia episodes

    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.

    Measured: From baseline (week 0) to week 20

  5. Change in ADA of GZR4

    Blood samples will be analysed for anti-GZR4 antibodies

    Measured: From baseline (week 0) to week 16

  6. Change in Nab of GZR4

    Blood samples will be analysed for Nab

    Measured: From baseline (week 0) to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start11 Aug 2023
  3. Primary completion13 Jul 2024
  4. Study completion8 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202079
Sponsor's protocol ID
GL-GZR-CH2007
Status last verified
Jan 2025
First submitted
2 Jan 2024
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen L, Dong X, Zhang Q, Wang H, Zhu H, Cheng Z, Deng X, Wang G, Zhang J, Liu X, Zhao J, Hao C, Xie T, He A, Li Y, Chen W. Once-weekly insulin GZR4 versus once-daily insulin degludec in Chinese people with type 2 diabetes: A multicenter, open-label, randomized, phase 2 trial. Metabolism. 2026 Jun;179:156592. doi: 10.1016/j.metabol.2026.156592. Epub 2026 Mar 14.

    PubMed 41833659

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GZR4 Injection and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Gan and Lee Pharmaceuticals, USA at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From baseline (week 0) to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06202079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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