This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.
Female or male，age 18 to 75.
Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
HbA1c of 7.0-10.5 %.
Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
History of pancreatitis (acute or chronic).
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
Subjects presently classified as being in New York Heart Association Class IV.
Parallel
QLG1091
DrugOral administration once-daily.
Rybelsus
DrugOral administration once-daily
Change in HbA1c
Change from baseline in HbA1c was evaluated at Week 26
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This trial is not recruiting at the moment. You can still explore other options:
