Product image of Komboglyze (Metformin Hydrochloride, Saxagliptin) supplied by GNH India

Komboglyze

Active Ingredient:
Metformin Hydrochloride, Saxagliptin
Origin:
EU

Komboglyze (Metformin Hydrochloride, Saxagliptin)

Metformin Hydrochloride and Saxagliptin, the active ingredient in Komboglyze, is a Biguanide and DPP‑4 inhibitor presented as a tablet for oral use. It is indicated for the management of type 2 diabetes mellitus in adult patients, helping to control blood glucose levels. The combination leverages complementary mechanisms to improve glycemic control while minimizing the risk of hypoglycemia.

GNH India supplies Komboglyze as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and regulatory requirements across multiple markets.

Manufacturer / TM Owner

Astrazeneca Ab

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Indications & Clinical Uses

Komboglyze is used in the management of type 2 diabetes mellitus, targeting hyperglycemia through complementary mechanisms.

  • Type 2 diabetes mellitus: improves overall glycemic control and lowers HbA1c levels.
  • Hyperglycemia associated with insulin resistance: enhances insulin sensitivity and increases glucose‑dependent insulin secretion.
  • Inadequate response to metformin alone: adds DPP‑4 inhibition to achieve target glucose levels.
  • Adjunct to lifestyle therapy: supports glucose regulation when diet and exercise are insufficient.
  • Cardiovascular risk considerations: may provide modest benefit on blood pressure and lipid profile when combined with standard care.

How It Works

  • Metformin Hydrochloride reduces hepatic gluconeogenesis and increases peripheral insulin sensitivity by activating AMP‑activated protein kinase. Saxagliptin selectively inhibits dipeptidyl peptidase‑4, preventing degradation of incretin hormones (GLP‑1 and GIP), thereby enhancing glucose‑dependent insulin secretion and suppressing glucagon release. Metformin also improves intestinal glucose uptake, while saxagliptin’s effect persists throughout the dosing interval, providing sustained glycemic control.

Side Effects

Komboglyze may be associated with a range of adverse reactions, varying from mild to serious.

Common Side Effects

  • Nausea: mild gastrointestinal upset.
  • Diarrhea: loose stools.
  • Headache: transient cranial discomfort.
  • Upper respiratory tract infection: mild cold‑like symptoms.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Lactic acidosis: rare but potentially life‑threatening metabolic disturbance.
  • Pancreatitis: severe abdominal pain with elevated enzymes.
  • Severe hypoglycemia: especially when combined with other glucose‑lowering agents.
  • Allergic reactions: rash, angioedema, or anaphylaxis may occur.

Precautions & Warnings

When prescribing Komboglyze, clinicians should consider several precautionary measures to ensure patient safety.

  • Renal function: assess creatinine clearance before initiation and monitor periodically.
  • Hepatic impairment: use with caution in patients with liver disease.
  • Risk of lactic acidosis: avoid in patients with conditions predisposing to hypoxia.
  • Concomitant sulfonylureas: monitor for hypoglycemia and adjust dose if needed.
  • Pregnancy and lactation: safety not established; weigh potential benefits against risks.
  • Store at ambient temperature: keep below 25°C in original packaging, protect from moisture.

Avoid Interactions

Komboglyze can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Iodinated contrast agents: may precipitate acute renal failure when combined with metformin.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase saxagliptin exposure.
  • Insulin or sulfonylureas: heightened risk of hypoglycemia.

Moderate Interactions (Monitor Closely)

  • Diuretics (thiazides): may affect blood glucose control.
  • Beta‑blockers: can mask hypoglycemia symptoms.
  • Rifampin: may reduce saxagliptin plasma levels.

Frequently Asked Questions

Komboglyze is a fixed‑dose oral tablet that combines metformin hydrochloride and saxagliptin. It is prescribed for adult patients with type 2 diabetes mellitus to improve overall glycemic control, helping to lower fasting and post‑prandial blood glucose levels when diet and exercise alone are insufficient.

Metformin hydrochloride lowers blood glucose primarily by inhibiting hepatic gluconeogenesis and enhancing peripheral insulin sensitivity. It activates AMP‑activated protein kinase, which reduces glucose production in the liver and improves glucose uptake in muscle tissue, contributing to better glycemic control without directly stimulating insulin secretion.

Saxagliptin is a selective dipeptidyl peptidase‑4 (DPP‑4) inhibitor. By blocking DPP‑4, it prevents the rapid breakdown of endogenous incretin hormones such as GLP‑1 and GIP, which in turn increase glucose‑dependent insulin release and suppress glucagon secretion, aiding in the reduction of blood glucose after meals.

The specific dose of Komboglyze is determined by the prescribing healthcare professional based on the individual’s clinical condition, renal function, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

The safety of Komboglyze in pregnancy and lactation has not been established. Clinicians must weigh the potential benefits against possible risks and consider alternative treatments when treating pregnant or nursing women with type 2 diabetes.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Komboglyze offers a dual mechanism by combining a biguanide (metformin) with a DPP‑4 inhibitor (saxagliptin), providing both insulin sensitisation and enhanced incretin effect. This contrasts with monotherapy agents such as sulfonylureas, which primarily increase insulin secretion, or SGLT2 inhibitors, which act on renal glucose reabsorption.

Komboglyze tablets should be stored at ambient temperature, preferably below 25 °C, in the original blister or bottle to protect them from moisture and light. Keep the medication out of reach of children and do not use after the expiry date.

Komboglyze is taken orally, usually once daily with the evening meal, unless otherwise directed by the prescriber. The tablet should be swallowed whole with a glass of water and not crushed or chewed, to ensure proper absorption.

The most serious adverse events to monitor include lactic acidosis, which is rare but life‑threatening, and acute pancreatitis. Patients should report any sudden abdominal pain, persistent nausea, or unexplained fatigue promptly, and clinicians should assess renal and hepatic function regularly.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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