Huatangning Dorzagliatin Tablets

1. Indications and Usage
Type 2 Diabetes Mellitus (T2DM):
Indicated to improve glycemic control in adults with type 2 diabetes mellitus.
Monotherapy: As monotherapy in combination with diet and exercise.
Combination Therapy: In combination with metformin when glycemic control is not adequately achieved with metformin alone.
Contraindications:
Not indicated for the treatment of type 1 diabetes mellitus, diabetic ketoacidosis, or hyperosmolar hyperglycemic state.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY.
Recommended Dosage:
Dose: 75 mg administered orally twice daily (BID).
Timing: Take within 1 hour before breakfast and dinner.
Administration Instructions:
Swallow tablets whole with water.
Missed Dose:
If a dose is missed, do not take it. Resume at the regularly scheduled time for the next dose.
3. Mechanism of Action
Glucokinase Activator (GKA):
Dorzagliatin is a novel small-molecule positive allosteric activator of glucokinase (GK).
Glucose Sensing and Homeostasis:
GK acts as the “glucose sensor” in pancreatic islet cells and hepatocytes. Dorzagliatin repairs defective islet function and improves glucose sensitivity by activating GK in both the pancreas (increasing early-phase insulin secretion) and the liver (improving glucose reserve function).
4. Safety and Warnings
Hypoglycemia:
While clinical trials showed a low incidence of hypoglycemia, caution should be exercised when used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.
Hepatic Impairment:
Mild (Child-Pugh A): No dose adjustment required.
Moderate/Severe (Child-Pugh B/C): Not recommended due to increased drug exposure.
Renal Impairment:
No dose adjustment is required for patients with renal impairment, including those with end-stage renal disease.
5. Adverse Reactions
Most Common:
Elevated alanine aminotransferase (ALT), elevated liver enzymes, elevated gamma-glutamyl transferase (GGT), hypertriglyceridemia, and dyslipidemia.
6. Drug Interactions
CYP3A4 Modulators:
Dorzagliatin is metabolized by CYP3A4. Avoid concomitant use with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) or strong inducers (e.g., rifampicin) to prevent altered drug exposure.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Dorzagliatin (Available in 75 mg tablets).
Storage:
Store in a tightly closed container in a dry place at a temperature not exceeding 30°C.