Janumet XR® is the global commercial brand name, and Beilisu® is its Chinese brand name developed by Chiatai Tianqing. It is an oral fixed-dose combination tablet of sitagliptin (DPP-4 inhibitor) and extended-release metformin hydrochloride. Sitagliptin elevates active incretin hormone levels, while metformin reduces hepatic glucose production and improves insulin sensitivity; the combined formulation exerts synergistic hypoglycemic effects.
Main Indications
Treatment of type 2 diabetes mellitus in adult patients, to improve glycemic control when sitagliptin and metformin are appropriate.
Clinical Research
Global multicenter phase III randomized controlled trials verified that the fixed combination achieved superior HbA1c reduction versus sitagliptin or metformin monotherapy;
Comparative trials demonstrated low risk of hypoglycemia compared with sulfonylurea combination regimens;
Long-term extension studies confirmed sustained glycemic control and good gastrointestinal tolerability profile;
Dose-finding studies validated the efficacy and safety of the 50 mg/500 mg strength;
Chinese registration clinical trials confirmed its hypoglycemic efficacy and controllable adverse reactions in Chinese type 2 diabetic populations.
Common Side Effects
Common mild adverse reactions: Diarrhea, nausea, abdominal distension, flatulence, nasopharyngitis, headache;
Severe but uncommon risks: Lactic acidosis, pancreatitis, severe arthralgia, bullous pemphigoid and hypersensitivity reactions.
Approval Status in China
Original drug Janumet XR® (Sitagliptin and Metformin Hydrochloride Extended-release Tablets). This domestic generic drug, marketed under brand name Beilisu® (reference brand name Janumet XR®), was officially approved for marketing in China in 2023, with the specification of sitagliptin 50mg and metformin hydrochloride 500mg per tablet, 60 tablets per bottle. It is currently a prescription drug.
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