Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With 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: GZR101-80, GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM). 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 Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin
Overview
This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.
Interventions
- Drug GZR101-80
Administered SC - Drug GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
Administered SC
Primary outcome measures
- Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. [Time frame: Baseline , 16 weeks]
Secondary outcome measures (2)
- Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment [Time frame: Baseline , 16 weeks]
- Safety Endpoints [Time frame: Baseline , 17 weeks]
Eligibility criteria
Inclusion criteria
- Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
- At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
Exclusion criteria
- Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.
- Grade 3 hypoglycemia within 3 months before screening.
- Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.
- Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor at screening.
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
- Gan & Lee Pharmaceuticals — Beijing
Identifiers
NCT: NCT07387003 · GZR101-T2D-203