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
Gan and Lee Pharmaceuticals, USA
60 participants
Jun 28, 2024
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
Inclusion Criteria4
- \. 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.
- At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
- Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
Exclusion Criteria5
- Presence or history of malignant neoplasm prior to screening.
- Known or suspected hypersensitivity to investigational medical product(s) or related products.
- Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
- 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.
- \. Participated in another interventional clinical study within 4 weeks prior to randomization.
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Interventions
Once daily
Once daily
Once daily
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06558708