RECRUITINGPhase 2INTERVENTIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 1\. Signed the willing to sign a consent form 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 willing to sign a consent form, 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
GZR101 Injection
Once daily
DRUG
GZR33 Injection
Once daily
DRUG
Insulin aspart
Once daily
Locations (1)
Study Site 01
Tianjin, China