Implementing an optimized glucose-lowering strategy with a novel once daily modified release gliclazide formulation

Area of Science:

• Endocrinology
• Pharmacology
• Diabetes Management

Background:

• Type 2 diabetes mellitus (T2DM) affects millions globally, necessitating effective glycemic control.
• Gliclazide modified release (MR) is a common treatment, but its titration profile requires real-world validation.

Purpose of the Study:

• To evaluate the 6-month titration profile and efficacy of a new scored gliclazide MR 60 mg formulation.
• To assess glycemic control, safety, and adherence in diverse T2DM patient populations.

Main Methods:

• An international study involving 7170 adults with T2DM and HbA1c ≥ 7.5% not on insulin.
• Participants received gliclazide MR 60 mg once daily, with uptitration up to 120 mg, as first-line, add-on, or switch therapy.
• Evaluated glycemic control, weight changes, hypoglycemia incidence, and treatment adherence over 6 months.

Main Results:

• 92% of patients reached their optimal dose by month 6, with significant HbA1c reductions across all treatment strategies (FIRST: -1.98%, ADD: -1.74%, SWITCH: -1.61%).
• 65.3% achieved target HbA1c ≤ 7.0% within an average of 80.1 days.
• The treatment demonstrated a favorable safety profile with minimal severe hypoglycemia (0.06%) and modest weight loss, alongside high patient-reported adherence (95.5%).

Conclusions:

• Progressive uptitration of gliclazide MR 60 mg is an effective and safe strategy for managing suboptimal glycemic control in T2DM.
• The formulation supports high adherence and offers a viable treatment option across different stages of diabetes management.