Clinical trial
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT06778967
Active, not recruitingPhase 3Interventional
What this study is about
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus (T2DM)
Full registry criteria
Inclusion Criteria: * T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended). * Antidiabetic drugs that meet any of the following within 8 weeks before screening: * A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ; * A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors; * A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose \< 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas. * HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory). * BG \< 15 mmol/L at screening (central laboratory). Exclusion Criteria: * Type 1 diabetes mellitus or special type of diabetes mellitus. * Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization. * Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization. * History of acute or chronic pancreatitis and pancreatic injury before screening. * History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening. * Any laboratory test indicator meeting the following criteria at screening or before randomization: * Calcitonin level ≥ 50 ng/L (pg/mL) at screening. * ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN. * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3). * Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL. * Blood amylase or lipase \> 1.5 × ULN. * Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.
Treatments and study arms
GZR18
Drug
Administered SC
semaglutide
Drug
Administered SC
Primary outcomes
Change from Baseline in Hemoglobin A1c (HbA1c)(%)Baseline, Week 44
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Tianjin Medical University General Hospital🇨🇳 Tianjin, China