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Recruiting NCT06558708

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

Phase II Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GZR101 Injection, GZR33 Injection, Insulin aspart.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug GZR101 Injection
    Once daily
  • Drug GZR33 Injection
    Once daily
  • Drug Insulin aspart
    Once daily

Primary outcome measures

  • Change in HbA1c [Time frame: Week 0, week 16]
Secondary outcome measures (4)
  • Change in Fasting Plasma Glucose (FPG) [Time frame: Week 0, Week 16]
  • Change in 7-point SMPG profile [Time frame: Week 0, Week 16]
  • Incidence and Rate of Treatment-emergent AE/SAEs [Time frame: Week 0, Week 19]
  • Incidence and Rate of hypoglycemia Events [Time frame: Week 0, Week 19]

Eligibility criteria

Inclusion criteria

  • 1\. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
  • 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
  • 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
  • 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

Exclusion criteria

  • 1.Presence or history of malignant neoplasm prior to screening.
  • 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
  • 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
  • 4.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.
  • 5\. Participated in another interventional clinical study within 4 weeks prior to randomization.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Study Site 01 — Tianjin

Identifiers

NCT: NCT06558708 · GZR101-T2D-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗