HuaTangNing Dorzagliatin Tablets

1. Indications and Usage
Dorzagliatin tablets are indicated for improving glycemic control in adult patients with type 2 diabetes mellitus. It can be used as monotherapy or in combination with metformin when metformin alone is insufficient.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 75 mg taken twice daily.
Administration: It should be taken orally within one hour before breakfast and dinner. It can be taken with or without food.
Missed Dose: If a dose is missed, do not make up for it. Take the next dose at the regular time.
3. Mechanism of Action
Dorzagliatin is a brain-penetrant, allosteric activator of glucokinase (GK). It activates GK in the pancreatic islets, intestinal endocrine cells, and liver, restoring the physiological regulation of glucose homeostasis. This action improves glucose-dependent secretion of insulin and GLP-1, and reduces hepatic glucose output.
4. Safety and Warnings
Contraindications: It is not indicated for the treatment of type 1 diabetes mellitus, diabetic ketoacidosis, or hyperosmolar hyperglycemic state.
Hypoglycemia: When used as monotherapy, dorzagliatin has a low risk of hypoglycemia. However, when combined with insulin or sulfonylureas, the risk of hypoglycemia may increase.
Liver and Kidney: Use with caution in patients with hepatic impairment. No dosage adjustment is generally required for mild to moderate renal impairment, but caution is advised.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: In clinical trials, adverse reactions associated with dorzagliatin incidence ≥0.5% included hypertriglyceridemia, alanine aminotransferase increase, and elevated liver enzymes.
Clinical Research: Clinical studies demonstrated that dorzagliatin effectively reduced HbA1c and fasting plasma glucose in patients with type 2 diabetes.
6. Drug Interactions
Strong CYP3A4 Inducers: Strong inducers of CYP3A4 (e.g., rifampin) significantly decrease dorzagliatin exposure and should be avoided.
CYP3A4 Inhibitors: Inhibitors of CYP3A4 may increase dorzagliatin exposure.
Other Antidiabetics: When combined with other antidiabetic agents (e.g., metformin, insulin), the risk of hypoglycemia may be potentiated.
7. Pharmaceutical Information
Composition: Each tablet contains 75 mg of dorzagliatin.
Appearance: The tablets are light green to green, biconvex, round, film-coated tablets. One side is engraved with “H” and the other with “75”.
Storage: Store at controlled room temperature and protect from moisture.