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Year : 2020  |  Volume : 11  |  Issue : 3  |  Page : 175-182

Evaluation of type 2 diabetes treatment with gliclazide modified release in Azerbaijan (the EdiAzer study): Results from a 16-week observational clinical study

1 Azerbaijan State Institute for Physician Postgraduate Education, Baku, Azerbaijan
2 Republic Endocrinology Center, Baku, Azerbaijan
3 City Polyclinic No. 24, Baku, Azerbaijan
4 Central Hospital for Oil Workers, Baku, Azerbaijan
5 Nasraddin Tusi Clinic, Baku, Azerbaijan
6 City Polyclinic No. 34, Baku, Azerbaijan
7 Starlab Private Medical Center, Baku, Azerbaijan
8 Azerbaijani Medical University, Baku, Azerbaijan
9 Baku Private Clinic, Baku, Azerbaijan

Correspondence Address:
Dr. Valeh A Mirzazada
Azerbaijan State Institute for Physician Postgraduate Education, Baku.
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JOD.JOD_5_20

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Introduction: Type 2 diabetes is a major public health problem across all economic regions. This open-label study collected real-world data on patients presenting with type 2 diabetes in Azerbaijan treated with gliclazide modified release (MR). Materials and Methods: Newly-diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin were prescribed gliclazide MR 60mg (30–120mg/day) for 16 weeks. Primary study endpoints were changes in mean glycated hemoglobin A1c (HbA1c) and percentage of participants achieving HbA1c ≤7.0% and/or an HbA1c improvement ≥1.0%. Secondary endpoints included changes in mean fasting plasma glucose (FPG) and weight. Serious adverse events were monitored throughout the study. Results: Data from 105 patients were available for analysis. Mean age was 55.1 ± 10.4 years, 53.3% were female and 82.9% were overweight or obese. Mean duration of diabetes was 2.3 ± 2.6 years. A total of 44 patients were receiving metformin before study entry. At W0, 61 patients (58.1%) were prescribed gliclazide MR monotherapy, and 44 (41.9%) were prescribed gliclazide MR in combination with the metformin. At the end of the study, a statistically significant decrease was observed in mean HbA1c levels from 8.8% ± 1.4% to 7.6% ± 1.0% (P < 0.001). In addition, 30 (28.6%) patients achieved an HbA1c <7.0% (P < 0.0001), and 61 (58.1%) an HbA1c reduction of ≥1.0%. Reductions in FPG levels were statistically significant compared with baseline from week 2 onward. No weight gain was observed, and there were no serious adverse events, including no reports of severe hypoglycemia. Conclusion: Gliclazide MR is an effective and well-tolerated first- or second-line agent in type 2 diabetes and may be particularly valuable in low-to-middle income countries where therapeutic options are limited by accessibility and cost.

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