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Related Experiment Videos

Extended-release metformin hydrochloride. Single-composition osmotic tablet formulation.

Antona J Wagstaff1, David P Figgitt

  • 1Adis International Inc., Yardley, Pennsylvania, USA. demail@adis.com

Treatments in Endocrinology
|August 28, 2004
PubMed
Summary

Metformin XT, an extended-release metformin formulation, offers comparable efficacy to immediate-release metformin for type 2 diabetes management. Gastrointestinal adverse events remain common with both formulations.

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Area of Science:

  • Pharmacology
  • Endocrinology
  • Drug Delivery Systems

Background:

  • Metformin hydrochloride (metformin XT) is a novel extended-release (ER) osmotic tablet formulation.
  • It releases metformin at a controlled rate via a semipermeable coating over an osmotic core.

Purpose of the Study:

  • To evaluate the pharmacokinetics, efficacy, and tolerability of metformin XT.
  • To compare metformin XT with immediate-release (IR) metformin in patients with type 2 diabetes mellitus.

Main Methods:

  • Pharmacokinetic analysis of metformin XT and IR metformin.
  • Efficacy assessment based on changes in glycosylated hemoglobin (HbA1c) and fasting plasma glucose.
  • Evaluation of adverse events, particularly gastrointestinal issues.

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Main Results:

  • Metformin XT demonstrated predictable, dose-associated increases in metformin exposure.
  • Bioavailability of metformin XT was increased after food, unlike the IR formulation.
  • Metformin XT showed non-inferior efficacy compared to IR metformin in managing type 2 diabetes.
  • Gastrointestinal adverse events were common with metformin XT, similar to IR metformin.

Conclusions:

  • Metformin XT provides a viable extended-release option for type 2 diabetes treatment.
  • The formulation offers comparable efficacy to immediate-release metformin with a once-daily dosing regimen.
  • Patients should be aware of the potential for common gastrointestinal side effects.