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Gliclazide modified release.

Jane K McGavin1, Caroline M Perry, Karen L Goa

  • 1Adis International Limited, Auckland, New Zealand.

Drugs
|June 22, 2002
PubMed
Summary
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Gliclazide modified release (MR) offers effective 24-hour glycemic control for type 2 diabetes. This new formulation demonstrates comparable efficacy and tolerability to immediate-release gliclazide, with a low risk of hypoglycemia.

Area of Science:

  • Pharmacology
  • Endocrinology
  • Diabetes Mellitus Research

Background:

  • Gliclazide modified release (MR) is a novel, once-daily formulation designed for type 2 diabetes management.
  • Its hydrophilic matrix ensures progressive drug release, aligning with the 24-hour glycemic profile of untreated patients.
  • The formulation exhibits high bioavailability, unaffected by food intake.

Purpose of the Study:

  • To evaluate the efficacy and tolerability of gliclazide MR compared to gliclazide immediate release (IR).
  • To assess the glycemic control, including fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) levels.
  • To investigate the safety profile, including adverse events and hypoglycemic episodes.

Main Methods:

  • A randomized, double-blind, multicenter study comparing gliclazide MR (30-120 mg/day) with gliclazide IR (80-320 mg/day).

Related Experiment Videos

  • Treatment duration was 10 months, with extended observation for some patients up to 24 months.
  • Efficacy endpoints included changes in HbA1c and FPG; safety assessments monitored adverse events and hypoglycemia.

    • Main Results:

    • Gliclazide MR demonstrated similar efficacy to gliclazide IR in reducing HbA1c and FPG over 10 months.
    • The drug was particularly effective in patients previously treated with diet alone, showing significant HbA1c reductions.
    • Gliclazide MR exhibited comparable tolerability to gliclazide IR, with infrequent symptomatic hypoglycemia and stable body weight.

    Conclusions:

    • Gliclazide MR provides effective and well-tolerated glycemic control for type 2 diabetes mellitus.
    • The once-daily modified-release formulation offers a convenient alternative to immediate-release gliclazide.
    • Further research could explore its long-term benefits and specific patient subgroups.