Drug reference

Glimepiride + Metformin + Voglibose

Sulfonylurea · Antidiabetic

Also known as Tripride, Glycomet Trio, Amaryl MV, Zita-Met Plus V, Volibo M G

SulfonylureaAntidiabeticATC A10BD (Combinations of oral blood glucose lowering drugs); individual components are Glimepiride (A10BB12), Metformin (A10BA02), Voglibose (A10BF03).

CDSCO approvedATC A10BD (Combinations of oral blood glucose lowering drugs); individual components are Glimepiride (A10BB12), Metformin (A10BA02), Voglibose (A10BF03).

Pharmacokineticsplasma · t hours

ONSET: 2.5h · Glimepiride: Within 2-3 hours. Metformin: Gradual onset over days to weeks. Voglibose: Rapid, within 1 hour after administration.
PEAK: 3h · Glimepiride: 2-4 hours. Metformin: Plasma peak concentrations 2-6 hours (standard release); 4-8 hours (sustained release). Voglibose: Peak effect on postprandial glucose occurs around 1 hour after dosing.
t½: 7h · Glimepiride: 5-9 hours. Metformin: Plasma elimination half-life is approximately 2-6 hours, but blood half-life is 9-17 hours. Voglibose: Systemic half-life is approximately 2 hours (for the negligible absorbed amount).
DURATION: 11h · Glimepiride: Up to 24 hours. Metformin: 10-12 hours (standard release), longer for sustained release formulations. Voglibose: Postprandial glucose lowering effect lasts approximately 3 hours.

EXCRETION

—

not curated

INTERACTIONS

—

none in our sources

PREGNANCY

Contraindicated. Oral antidiabetic agents are generally not recommended during pregnancy for the treatment of Type 2 Diabetes; insulin therapy is preferred to achieve glycemic control and minimize fetal risk.

FDA category + note

Mechanism

This fixed-dose combination targets multiple facets of Type 2 Diabetes Mellitus pathophysiology. Glimepiride, a sulfonylurea, stimulates insulin release from pancreatic beta cells. Metformin, a biguanide, primarily reduces hepatic glucose production, decreases intestinal glucose absorption, and improves peripheral insulin sensitivity. Voglibose, an alpha-glucosidase inhibitor, delays the digestion and absorption of carbohydrates in the small intestine, thereby reducing postprandial glucose excursions. Combination rationale: This FDC offers a comprehensive approach to managing Type 2 Diabetes by addressing three key pathophysiological defects simultaneously. Glimepiride targets impaired insulin secretion, Metformin tackles insulin resistance and excessive hepatic glucose production, while Voglibose controls postprandial hyperglycemia by delaying carbohydrate absorption. This triple combination aims to achieve tighter glycemic control, reduce HbA1c, and potentially minimize the pill burden for patients requiring multiple antidiabetic agents.

Indications

Management of Type 2 Diabetes Mellitus in adults as an adjunct to diet and exercise, when glycemic control is not achieved with dual therapy (e.g., Metformin + Sulfonylurea or Metformin + Alpha-glucosidase Inhibitor) or when triple therapy is deemed appropriate by a physician.

Dosing

Adult: Typically, one tablet once or twice daily, taken with meals. Common strengths available in India include Glimepiride 1mg/2mg/3mg + Metformin 500mg/1000mg (usually sustained-release) + Voglibose 0.2mg/0.3mg. Dosing should be individualized based on the patient's current glycemic control and tolerance.
Pediatric: Not recommended for use in pediatric patients due to lack of established safety and efficacy data.
Renal adjustment: Contraindicated if eGFR <30 mL/min/1.73m². Dose adjustment is required for eGFR 30-60 mL/min/1.73m² for Metformin (reduce dose) and Glimepiride (reduce dose, increased risk of hypoglycemia). Voglibose should be used with caution in renal impairment, and generally avoided in severe cases.
Hepatic adjustment: Contraindicated in severe hepatic impairment. Use with extreme caution in mild to moderate hepatic impairment; monitor liver function closely and consider dose reduction for glimepiride and metformin.
Geriatric: Use with caution. Start with the lowest effective dose and titrate slowly. Renal function should be monitored frequently due to increased risk of renal impairment and lactic acidosis in the elderly.
Max dose: The maximum daily doses for individual components are typically: Glimepiride 8mg, Metformin 2000mg, Voglibose 0.9mg. However, the maximum dose of the FDC is dictated by the highest strength available in the specific combination formulation.

Pharmacokinetics

Onset

Glimepiride: Within 2-3 hours. Metformin: Gradual onset over days to weeks. Voglibose: Rapid, within 1 hour after administration.

Peak effect

Glimepiride: 2-4 hours. Metformin: Plasma peak concentrations 2-6 hours (standard release); 4-8 hours (sustained release). Voglibose: Peak effect on postprandial glucose occurs around 1 hour after dosing.

Duration

Glimepiride: Up to 24 hours. Metformin: 10-12 hours (standard release), longer for sustained release formulations. Voglibose: Postprandial glucose lowering effect lasts approximately 3 hours.

Half-life

Glimepiride: 5-9 hours. Metformin: Plasma elimination half-life is approximately 2-6 hours, but blood half-life is 9-17 hours. Voglibose: Systemic half-life is approximately 2 hours (for the negligible absorbed amount).

Bioavailability

Glimepiride: 100%. Metformin: 50-60% (absolute). Voglibose: Systemic absorption is negligible (<0.2%).

Protein binding

Glimepiride: >99% to plasma proteins. Metformin: Negligible. Voglibose: Negligible systemic absorption and protein binding.

Metabolism

Glimepiride: Extensively metabolized in the liver by CYP2C9 to active and inactive metabolites. Metformin: Not metabolized; excreted unchanged. Voglibose: Minimal systemic metabolism; primarily metabolized by intestinal bacteria.

Excretion

Glimepiride: Renal (60%) and fecal (40%) as metabolites. Metformin: Primarily renal, excreted unchanged (approximately 90% within 24 hours). Voglibose: Mainly excreted unchanged in feces (as the drug acts locally in the gut); minimal systemic absorption means minimal renal excretion of parent drug.

Contraindications

Type 1 Diabetes Mellitus
Diabetic ketoacidosis
Severe renal impairment (eGFR <30 mL/min/1.73m²)
Severe hepatic impairment
Congestive heart failure requiring pharmacological treatment
Acute or chronic metabolic acidosis, including lactic acidosis
Hypersensitivity to glimepiride, metformin, voglibose, other sulfonylureas, sulfonamides, or any excipients
Acute myocardial infarction
Severe infection or trauma
Dehydration
Acute alcoholism or chronic alcohol dependence
Gastrointestinal obstruction or chronic inflammatory bowel disease (for voglibose)
Pregnancy and lactation

Side effects

Common

Hypoglycemia (especially with Glimepiride)Gastrointestinal disturbances (e.g., diarrhea, nausea, vomiting, abdominal pain, flatulence) (common with Metformin and Voglibose)HeadacheDizzinessWeight gain (with Glimepiride)

Serious

Lactic acidosis (rare but potentially fatal, associated with Metformin, especially in patients with renal impairment, hepatic impairment, or other predisposing conditions)
Severe hypoglycemia (risk increased with Glimepiride, particularly in elderly or renally impaired patients)
Hepatotoxicity (rare, Glimepiride)
Hemolytic anemia (rare, Glimepiride)
Agranulocytosis, aplastic anemia, pancytopenia (rare, Glimepiride)
Vitamin B12 deficiency (with long-term Metformin use)
Hypersensitivity reactions

Pregnancy & lactation

Pregnancy

Lactation

Contraindicated. Glimepiride and Metformin are excreted into breast milk. Voglibose has negligible systemic absorption, but its safety in lactation is not established. Due to potential risks of hypoglycemia in the infant (from glimepiride) and accumulation (from metformin), breastfeeding is not recommended.