GZR4 vs Insulin for Type 2 Diabetes Management

A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin

Recruiting Phase 3 Interventional Study
Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Gan & Lee Pharmaceuticals. · Industry
Who this trial is looking for

This trial is looking for adults with type 2 diabetes who are currently using basal insulin. Participants will compare the new treatment GZR4 with another insulin option to see which works better and is safer.

Are You a Good Fit for This Trial?
Must be taking Basal insulin
Rules you out Type 1 diabetesSevere heart failure

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with type 2 diabetes for at least 180 days.
  • I currently use basal insulin.
  • I can provide informed consent for the trial.
  • I am willing to use reliable birth control if I can get pregnant.

You may not be able to join if

  • I have allergies to medications that affect diabetes treatment.
  • I am pregnant, breastfeeding, or planning to become pregnant.
  • I have had severe heart or brain problems in the last 6 months.
  • I have had cancer in the past 5 years, apart from some skin cancers.
  • I have high blood pressure with my systolic blood pressure above 160.
  • I have participated in another clinical study within the last 90 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol. * Males and females age ≥ 18 years at the time of…
Contacts

juan wu

010-56456739

juan.wu@ganlee.com

CONTACT