NAXGLIM-M2

Overview

NAXGLIM-M2 is indicated for newly diagnosed diabetic patients who need rapid reductions in elevated glucose levels. Delivering Glimepiride 2mg with Metformin Hydrochloride 500mg SR, it provides a stronger insulin secretory stimulus for patients presenting with higher baseline HbA1c values who require prompt glycaemic control.

The tagline "It's time to offer #QuickControlOfDiabetes" reflects the product's role as an intensified first-line combination where 1mg glimepiride alone would be insufficient to achieve rapid glucose normalisation in significantly hyperglycaemic newly diagnosed patients.

Indications

• Newly diagnosed Type 2 diabetic patients with significantly elevated fasting blood glucose
• Patients requiring rapid reductions in elevated glucose levels
• Type 2 DM with HbA1c between 8.0–10% requiring more intensive initial therapy
• Patients inadequately controlled on NAXGLIM-M1 (Glimepiride 1mg + Metformin 500mg SR)
• Simplification for patients on separate Glimepiride 2mg + Metformin 500mg SR

Mechanism of Action

Glimepiride (2mg) binds to sulfonylurea receptors (SUR1) on pancreatic β-cells, closing ATP-sensitive K+ channels, depolarising the cell membrane and triggering insulin exocytosis. At 2mg, glimepiride provides approximately 1.5–2× greater insulin secretory stimulus versus 1mg — addressing more pronounced fasting and postprandial hyperglycaemia. Plasma half-life is 5–8 hours.

Metformin HCl SR activates hepatic AMPK, reducing gluconeogenesis and glycogenolysis, while enhancing peripheral glucose uptake. The SR formulation maintains therapeutic plasma levels over 10–12 hours, delivering sustained glucose-lowering with improved GI tolerability.

Dosage & Administration

• Standard dose: 1 tablet once or twice daily with meals
• Maximum: Glimepiride 4mg + Metformin 2000mg daily (using appropriate combinations)
• Take with or immediately after the first bite of a meal
• Swallow whole — do not crush or divide SR tablets
• Renal monitoring: Check eGFR at initiation and at least annually; withhold if eGFR < 30

Contraindications

• Type 1 diabetes mellitus or diabetic ketoacidosis
• eGFR < 30 mL/min/1.73m² (severe renal impairment)
• Hypersensitivity to glimepiride, sulfonamides, metformin, or excipients
• Severe hepatic impairment
• Acute decompensated heart failure (risk of lactic acidosis)
• Pregnancy and lactation — not recommended
• Concurrent iodinated contrast use — withhold 48 hours prior and post-procedure