INTRODUCTION
Diabetes Mellitus is a common endocrine disorder whose prevalence is increasing worldwide. 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 global population within this age group. This number is projected to rise to 852.5 million by 2045. Approximately 3.4 million deaths occur annually worldwide due to diabetes and its related complications.
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 globally in terms of the number of people with diabetes and is projected to move to seventh position by 2050, with an estimated 23.1 million individuals affected by Type 2 Diabetes Mellitus (T2DM). According to the World Health Organization (WHO), diabetes is expected to become the seventh leading cause of death worldwide by 2030. In addition to its health consequences, diabetes imposes a substantial economic burden on healthcare systems globally. In 2017, healthcare expenditure attributed to diabetes was estimated at approximately USD 727 billion.
The primary goal of managing Type 2 Diabetes Mellitus is not only to achieve optimal glycemic control but also to reduce the risk of long-term microvascular and macrovascular complications. Along with lifestyle modification, insulin therapy plays a crucial role in achieving glycemic targets and improving metabolic abnormalities associated with Type 2 diabetes.
Dietary modification and lifestyle changes remain the first-line interventions for maintaining optimal glycemic control, defined as HbA1c <7.0%, fasting blood sugar (FBS) between 4.4 and 7.2 mmol/L, and postprandial blood glucose levels less than 10 mmol/L two hours after breakfast. Various oral and injectable antidiabetic agents are used based on their effectiveness, cost, risk of hypoglycemia, effect on body weight, and patient preference.
When insulin therapy is indicated, the choice of regimen depends on several factors, including efficacy, safety, convenience, and simplicity of administration. Basal-bolus (BB) insulin therapy consists of multiple daily injections, including basal insulin once or twice daily combined with rapid-acting bolus insulin before meals, thereby mimicking physiological insulin secretion. In contrast, premixed (PM) insulin combines rapid-acting and intermediate-acting insulin in a single preparation, requiring fewer daily injections and potentially reducing the risk of hypoglycemia.
Several studies have compared the effectiveness of basal-bolus and premixed insulin regimens. Some investigations have demonstrated similar efficacy in achieving glycemic control, while others have reported differences in treatment outcomes. Home et al. reported significant reductions in HbA1c, fasting blood glucose, and postprandial blood glucose levels in both treatment groups, although significant weight gain was observed in both regimens. Other studies have also identified differences in the frequency of hypoglycemic events between basal-bolus and premixed insulin therapies.
Therefore, this study was conducted to evaluate and compare premixed insulin and basal-bolus insulin regimens in the management of Type 2 Diabetes Mellitus. The findings may assist physicians in selecting the most appropriate insulin regimen according to individual patient requirements and clinical situations.
MATERIALS AND METHODS
This cross-sectional quasi-experimental study was conducted at the Endocrinology Outpatient Department of Dhaka Medical College Hospital, Dhaka, and the Outpatient Department of Ibrahim General Hospital (National Healthcare Network), Mirpur, Dhaka. The study period extended from July 2018 to June 2019.
Ethical approval was obtained from the Ethical Review Committees of both Dhaka Medical College Hospital and Ibrahim General Hospital. These hospitals were selected for convenience in communication and data collection. Patients were recruited according to predefined inclusion and exclusion criteria. Written informed consent was obtained from all participants after explaining the objectives and procedures of the study.
Inclusion Criteria


Diagnosed cases of Type 2 Diabetes Mellitus.


Patients prescribed premixed 30/70 insulin or glargine-based basal-bolus insulin regimen for the first time.


Patients willing to continue insulin therapy throughout the 12-week study period.


Male and female patients aged between 30 and 70 years.


Exclusion Criteria


Patients receiving medications such as steroids, thiazides, or beta-blockers that may interfere with blood glucose levels.


Pregnant and lactating women.


Patients with serious concomitant illnesses, chronic kidney disease, or chronic liver disease.


A total of 135 patients were initially interviewed. During the first visit, baseline information including height, weight, body mass index (BMI), fasting blood glucose (FBG), blood glucose level two hours after breakfast (2-hour ABF), and HbA1c values were collected from laboratory reports and recorded in a structured data collection form.
Participants were then advised to return for a follow-up visit after 12 weeks with updated laboratory investigations. During the follow-up visit, information regarding FBG, 2-hour ABF, HbA1c, body weight, and any history of hypoglycemic episodes during the previous three months was recorded.
Approximately 35 patients were excluded during follow-up because some did not return for review visits, while others failed to complete the recommended investigations. Consequently, a total of 100 patients were included in the final analysis. Among them, 50 patients receiving premixed 30/70 insulin were assigned to Group I, and 50 patients receiving glargine-based basal-bolus insulin were assigned to Group II.
Qualitative variables were expressed as frequencies and percentages and compared using the Chi-square test. Quantitative variables were expressed as mean ± standard deviation (SD). A p-value of ≤0.05 was considered statistically significant at a 95% confidence interval. Data analysis was performed using Statistical Package for Social Sciences (SPSS) version 25.0.