Type 2 Diabetes (T2DM)
Conditions
Brief summary
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
DRUGGZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
Administered SC
DRUGGZR101-80
Administered SC
Sponsors
Gan & Lee Pharmaceuticals.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. At the age of 18-75 (inclusive) at the time of informed consent, male or female. 3. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening. 4. 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
1. 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. 2. Grade 3 hypoglycemia within 3 months before screening. 3. 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. 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. | Baseline , 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment | Baseline , 16 weeks | — |
| Safety Endpoints | Baseline , 17 weeks | Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent |
Countries
China
Contacts
CONTACTWei Zhao
Outcome results
None listed