RecruitingPhase 2NCT06558708

A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin


Sponsor

Gan and Lee Pharmaceuticals, USA

Enrollment

60 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different injectable medications for people with type 2 diabetes: GZR101 and GZR33-70, both given once daily. The goal is to see which version is more effective, better tolerated, and safer for managing blood sugar. **You may be eligible if...** - You are between 18 and 75 years old (male or female) - You have had a type 2 diabetes diagnosis for at least 6 months - You have signed the informed consent form **You may NOT be eligible if...** - You have a history of cancer - You have had a severe low blood sugar episode (Level 3) in the last 6 months - You were hospitalized for a heart attack, stroke, or severe heart failure in the last 6 months - You have participated in another clinical trial within the past 4 weeks - You have a known allergy to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGZR101 Injection

Once daily

DRUGGZR33 Injection

Once daily

DRUGInsulin aspart

Once daily


Locations(1)

Study Site 01

Tianjin, China

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NCT06558708


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