Diabetes is a chronic metabolic disease characterized by abnormalities in insulin secretion or insulin action, resulting in hyperglycemia. The two main types of diabetes mellitus are Type I and Type II. Type I diabetes usually develops during childhood or adolescence and is characterized by absolute insulin deficiency due to the destruction of pancreatic beta cells. Type II diabetes is the more common form and accounts for the majority of diabetes cases worldwide.
The prevalence of diabetes mellitus is increasing globally. According to the International Diabetes Federation (IDF) 2025, an estimated 589 million adults aged 20–79 years are currently living with diabetes, representing 10.5% of the world’s population in this age group. By 2045, this number is projected to increase to 852.5 million. Diabetes and its complications are responsible for approximately 3.4 million deaths worldwide each year. In Bangladesh, about 13.9 million people are living with diabetes, with a prevalence of 14.2% among adults aged 20–79 years. Bangladesh currently ranks eighth in the world in terms of the total number of people with diabetes and is projected to move to seventh position by 2050, with an estimated 23.1 million people affected by Type II diabetes mellitus.
Patients with diabetes are at increased risk of developing both microvascular and macrovascular complications, particularly when glycemic control is poor. Most adults with diabetes have at least one associated chronic disease, and up to 40% have three or more comorbid conditions. Hypertension is present in up to 75% of adults with diabetes. Other common comorbidities include dyslipidemia, cardiovascular disease, chronic kidney disease, non-alcoholic fatty liver disease, and obesity.
Type II diabetes mellitus accounts for approximately 90–95% of all diabetes cases. Several lifestyle-related factors contribute to its development, including obesity, sedentary lifestyle, physical inactivity, smoking, and alcohol consumption. Lifestyle modification and dietary management are considered the first-line approaches for achieving optimal glycemic control. When adequate control is not achieved through diet and exercise alone, pharmacological treatment becomes necessary. The selection of antidiabetic therapy depends on factors such as efficacy, cost, risk of hypoglycemia, weight gain, and patient preference.
Metformin is widely accepted as the first-line monotherapy for Type II diabetes mellitus. It lowers blood glucose levels by reducing hepatic glucose production, increasing glucose uptake and utilization in peripheral tissues, and improving insulin sensitivity. Metformin is generally not associated with weight gain or hypoglycemia. Gliclazide, a second-generation sulfonylurea, stimulates insulin secretion from pancreatic beta cells and improves insulin action in peripheral tissues. However, its use may be associated with hypoglycemia and weight gain.
Combination therapy with metformin and gliclazide has been shown to be effective in improving glycemic control among patients whose diabetes is inadequately controlled with monotherapy. Insulin therapy is another important treatment option that reduces the risk of microvascular complications and may also lower macrovascular risk in patients with Type II diabetes. However, insulin therapy is commonly associated with weight gain and hypoglycemia, which may occur due to an imbalance between insulin dosage and dietary intake.
This study was conducted to evaluate and compare the effects and outcomes of glycemic control achieved with gliclazide–metformin combination therapy versus insulin therapy among patients with Type II diabetes mellitus.
MATERIALS AND METHODS
This observational outpatient-based study was conducted at the Endocrinology Outpatient Department of Dhaka Medical College Hospital, Dhaka, and the Outpatient Department of Ibrahim General Hospital, Mirpur, Dhaka. The study was carried out over a period of one year from July 2018 to June 2019.
Ethical approval was obtained from the Ethical Review Committee of Dhaka Medical College Hospital and the authority of Ibrahim General Hospital. A total of 110 patients aged 30–70 years with Type II diabetes mellitus were selected purposively and divided into two groups.
Group I consisted of 55 patients who received combination therapy with gliclazide (80 mg) and metformin (500 mg) twice daily for 12 consecutive weeks. Group II consisted of 55 patients who received premixed insulin (30/70) twice daily for the same duration.
Baseline information including HbA1c, fasting blood glucose (FBG), blood glucose level two hours after breakfast, and body weight was recorded during the first visit using a structured data collection form. All participants were interviewed, and their demographic and clinical data were documented.
Patients were subsequently advised to return for a follow-up visit after 12 weeks with their laboratory investigation reports. During the follow-up visit, HbA1c, fasting blood glucose, post-breakfast blood glucose, body weight, and any history of hypoglycemic episodes during the preceding 12 weeks were recorded.
A considerable number of participants were lost to follow-up because some patients did not return for review visits, while others failed to complete the recommended laboratory investigations.
All collected data were checked, compiled, and analyzed using SPSS version 25.0. Statistical analysis was performed using Student’s t-test and Chi-square test. A p-value of ≤0.05 was considered statistically significant at a 95% confidence interval.