2nd Edition of Diabetes and Endocrinology World Conference 2026

Abstract

Abstract

Background: Type 2 diabetes mellitus (T2DM) is one of the most common chronic metabolic disorders worldwide and is associated with an increased risk of microvascular and macrovascular complications. Achieving adequate glycemic control remains a major therapeutic goal, particularly in the early stages of the disease. Combination therapy with oral glucose-lowering agents is widely used in clinical practice to improve metabolic control and delay disease progression. The combination of metformin with modified-release sulfonylurea therapy may provide effective improvement in glycemic parameters.

Objective: The aim of this study was to evaluate the clinical effectiveness of gliclazide modified release (MR) in combination with metformin in patients with type 2 diabetes mellitus.

Materials and Methods:This analysis was based on data from the EdiAzer study, which included 105 patients with type 2 diabetes mellitus. The duration of diabetes ranged from 0 to 10 years, with a mean duration of 2.3 years, indicating that most participants were in the relatively early stages of the disease. Approximately 61% of patients had a disease duration of less than three years.

Before inclusion in the study, patients had received different therapeutic approaches. Dietary recommendations were followed by 52.4% of participants, regular physical activity was reported by 35.2%, and 42.9% were receiving metformin therapy. Notably, 24.8% of participants had not received any antidiabetic treatment before enrollment.

Anthropometric assessment showed a high prevalence of excess body weight. The mean body mass index was 29.5 kg/m². Normal body weight was observed in 14.7% of patients, while 53.9% were overweight and 31.4% had obesity.

At baseline, the mean fasting plasma glucose level was 10.9 mmol/L, and the mean glycated hemoglobin level was 8.8%, reflecting insufficient glycemic control in the study population.

Patients received gliclazide MR in combination with metformin. Changes in carbohydrate metabolism parameters were assessed over a 16-week follow-up period.

Results: The study demonstrated significant improvement in glycemic control during the treatment period. Mean HbA1c decreased from 8.8% at baseline to 7.6% after 16 weeks of therapy (p < 0.001).

A reduction in HbA1c compared with baseline was observed in 98.1% of patients, indicating high overall effectiveness of the treatment regimen. The proportion of patients with HbA1c levels above 8.0% decreased from 65.7% at baseline to 32.4% at week 16 (p < 0.0001). At the same time, the proportion of patients achieving HbA1c levels below 7.0% increased to 28.6% by the end of the study.

A significant reduction in fasting plasma glucose was also observed. Mean fasting plasma glucose decreased from 10.9 mmol/L at baseline to 7.1 mmol/L after 16 weeks of treatment (p < 0.001).

The most pronounced decrease in fasting plasma glucose occurred during the initial weeks of therapy. During the first two weeks, the mean reduction in fasting plasma glucose was 2.1 mmol/L. Thereafter, the rate of reduction gradually slowed, although glycemic values remained significantly lower than baseline throughout the study period.

By the end of the study, fasting plasma glucose levels were lower than baseline in 94.3% of participants.

The combined primary endpoint, defined as achieving HbA1c below 7.0% and/or a reduction in HbA1c of at least 1.0%, was achieved in 69.5% of patients, demonstrating substantial clinical benefit of the treatment strategy.

Conclusion
The results of the EdiAzer study indicate that combination therapy with gliclazide MR and metformin is an effective strategy for improving glycemic control in patients with type 2 diabetes mellitus. Treatment was associated with significant reductions in both HbA1c and fasting plasma glucose within a relatively short period.

Most patients experienced clinically meaningful improvements in carbohydrate metabolism parameters. These findings support the use of gliclazide MR in combination with metformin as an effective therapeutic option, particularly in patients with early-stage type 2 diabetes mellitus and insufficient glycemic control.