Diabetes mellitus comprises a heterogeneous group of metabolic disorders characterized by persistent hyperglycaemia resulting from defects in insulin secretion, insulin action or both. Type 2 diabetes mellitus is the most common form of diabetes and accounts for the majority of cases worldwide. It is characterized by a combination of insulin resistance and progressive pancreatic beta-cell dysfunction. The burden of diabetes has increased considerably in both developed and developing countries. The International Diabetes Federation estimated that approximately 415 million adults worldwide were living with diabetes in 2015, with a substantial proportion of affected individuals residing in low- and middle-income countries.¹ India contributes significantly to the global diabetes burden because of its large population, changing dietary practices, increasing urbanization, reduced physical activity, obesity and genetic susceptibility.² Type 2 diabetes mellitus is frequently associated with hypertension, dyslipidaemia, obesity, cardiovascular disease, renal impairment and other chronic conditions. Persistent hyperglycaemia increases the risk of microvascular complications, including retinopathy, nephropathy and neuropathy, as well as macrovascular complications such as ischaemic heart disease, stroke and peripheral arterial disease. Effective glycaemic management is therefore essential to reduce symptoms, prevent acute metabolic complications and decrease the long-term risk of vascular complications. Management of type 2 diabetes mellitus involves lifestyle modification, dietary intervention, regular physical activity, patient education, glucose monitoring and pharmacological treatment. The principal pharmacological options available during the study period included biguanides, sulfonylureas, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides, dipeptidyl peptidase-4 inhibitors and insulin preparations. The selection of antidiabetic treatment depends on several factors, including the severity of hyperglycaemia, duration of diabetes, body weight, risk of hypoglycaemia, renal and hepatic function, associated illnesses, treatment cost, patient preferences and previous response to therapy. Metformin was regarded as the preferred initial pharmacological treatment for most adults with type 2 diabetes mellitus in the absence of contraindications or intolerance. Additional medicines were recommended when adequate glycaemic control could not be achieved with metformin and lifestyle modification alone.³⁻⁵ Type 2 diabetes mellitus is a progressive disorder. Although some patients initially achieve adequate glycaemic control with a single medicine, the gradual decline in beta-cell function frequently necessitates treatment intensification. Patients may therefore progress from monotherapy to dual therapy, triple-drug treatment or insulin-based therapy. This progression contributes to variation in prescribing patterns and increases the potential for polypharmacy, adverse effects, drug interactions and treatment non-adherence. The World Health Organization defines drug-utilization research as the study of the marketing, distribution, prescription and use of medicines in society, with particular emphasis on the resulting medical, social and economic consequences.³ Drug-utilization studies may be used to describe current prescribing practices, detect potentially irrational medicine use, compare treatment patterns across settings and assess the effects of educational or regulatory interventions. Prescription-pattern studies are particularly relevant in chronic diseases such as diabetes because treatment is usually continued for many years. Inappropriate selection of medicines, avoidable polypharmacy, excessive use of brand names, irrational fixed-dose combinations and delayed treatment intensification can affect treatment effectiveness, safety, adherence and affordability. Several Indian studies published before 2016 demonstrated considerable variation in antidiabetic prescribing. Differences were observed in the relative use of metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 inhibitors and insulin, as well as in the frequency of monotherapy and combination therapy.⁶⁻¹¹ These variations may be related to differences in patient characteristics, clinical setting, prescriber preference, medicine availability and affordability. Periodic assessment of antidiabetic prescribing patterns is therefore necessary at the institutional level. Such evaluation can identify commonly used medicines and combinations, measure the extent of generic prescribing and provide a basis for interventions promoting rational medicine use. The present study was undertaken to evaluate the utilization pattern of antidiabetic medicines among patients with type 2 diabetes mellitus attending Mamata Medical College & General Hospital, Khammam. Aim and Objectives Aim To study the utilization pattern of medicines prescribed for the management of type 2 diabetes mellitus at Mamata Medical College & General Hospital, Khammam. Primary objective To determine the prescribing pattern of antidiabetic medicines among patients diagnosed with type 2 diabetes mellitus. Secondary objectives 1. To determine the proportion of patients receiving monotherapy, dual therapy and triple therapy. 2. To identify the most frequently prescribed antidiabetic drug classes and individual medicines. 3. To evaluate the utilization of insulin preparations. 4. To assess the utilization of fixed-dose antidiabetic combinations. 5. To calculate the average number of antidiabetic medicines prescribed per patient. 6. To determine the proportion of antidiabetic medicines prescribed by generic name. 7. To examine the association between duration of diabetes and the number of antidiabetic medicines prescribed. 8. To describe the major comorbidities documented among the study participants.

Study design This was a prospective, observational, cross-sectional, prescription-based drug-utilization study. Study setting The study was conducted by the Department of Pharmacology in collaboration with the clinical departments involved in the management of diabetes mellitus at Mamata Medical College & General Hospital, Khammam, Telangana, India. Study duration The study was conducted over a period of one year, from November 2015 to October 2016. Study population Adult patients diagnosed with type 2 diabetes mellitus and receiving pharmacological treatment for glycaemic control were screened for participation. Sample size A total of 850 eligible patients were included during the study period. Sampling method Consecutive sampling was used. Eligible patients encountered during the study period were included until the required sample size was achieved. Inclusion criteria Patients were included when they fulfilled all the following criteria: 1. Age of 18 years or older. 2. Established diagnosis of type 2 diabetes mellitus. 3. Prescription of at least one antidiabetic medicine. 4. Attendance at the outpatient services of the study hospital during the study period. 5. Availability of the prescription and relevant clinical information. 6. Willingness to participate in the study. Exclusion criteria The following patients were excluded: 1. Patients diagnosed with type 1 diabetes mellitus. 2. Women with gestational diabetes mellitus. 3. Patients with secondary diabetes due to pancreatic disease, endocrinopathy or medicine use. 4. Patients presenting exclusively for emergency treatment of diabetic ketoacidosis or hyperosmolar hyperglycaemic state. 5. Patients with incomplete prescription or clinical records. 6. Patients not receiving pharmacological treatment for diabetes. 7. Patients unwilling to participate. Data-collection instrument A structured case-record form was prepared for collection of the following information: • age; • sex; • duration of diabetes; • body mass index, when available; • relevant glycaemic investigations; • associated comorbidities; • names of prescribed antidiabetic medicines; • pharmacological classes; • dosage forms; • routes of administration; • number of active antidiabetic ingredients; • use of monotherapy or combination therapy; • use of fixed-dose combinations; • use of insulin preparations; • generic or brand-name prescribing; and • concomitant medicines prescribed for associated illnesses. Data-collection procedure Eligible prescriptions were reviewed prospectively. Demographic and clinical information was recorded from the patient’s prescription, case record and relevant clinical documentation. Each patient was included only once in the principal analysis. When more than one prescription was available during the study period, the prescription at enrolment was used to describe the treatment pattern. The prescribed antidiabetic medicines were categorized according to their pharmacological class. Oral antidiabetic medicines and insulin preparations were analysed separately and in combination. Counting of antidiabetic drug items Each active antidiabetic ingredient was counted as one drug item. A fixed-dose combination containing two active ingredients was counted as two antidiabetic drug items when calculating the average number of active antidiabetic agents per prescription. For example, a fixed-dose tablet containing metformin and glimepiride was counted as one pharmaceutical formulation but two active antidiabetic drug items. Classification of treatment regimens Treatment was categorized according to the number of active antidiabetic ingredients: • Monotherapy: one active antidiabetic agent. • Dual therapy: two active antidiabetic agents. • Triple therapy: three active antidiabetic agents. Patients receiving insulin with one or more oral antidiabetic medicines were classified according to the total number of active agents. Drug-utilization indicators The following indicators were evaluated: 1. Total number of prescriptions studied. 2. Total number of antidiabetic drug items prescribed. 3. Average number of antidiabetic agents per prescription. 4. Percentage of patients receiving monotherapy. 5. Percentage of patients receiving dual therapy. 6. Percentage of patients receiving triple therapy. 7. Percentage of patients receiving insulin. 8. Percentage of patients receiving fixed-dose combinations. 9. Percentage of antidiabetic drug items prescribed by generic name. 10. Frequency of individual antidiabetic medicines. Outcome measures The primary outcome measure was the distribution of prescribed antidiabetic medicines. Secondary outcome measures included: • intensity of antidiabetic treatment; • insulin utilization; • fixed-dose combination utilization; • generic prescribing; • average number of antidiabetic medicines; and • association between duration of diabetes and treatment intensity. Statistical analysis Data were entered into a spreadsheet and analysed using descriptive and inferential statistics. Continuous variables were expressed as mean and standard deviation. Categorical variables were presented as frequencies and percentages. The chi-square test was used to assess the association between duration of diabetes and intensity of antidiabetic therapy. A p-value below 0.05 was considered statistically significant. Ethical considerations Written informed consent was obtained from eligible participants before enrolment. Patient identity and confidential clinical information were not included in the analysis or reporting.

Study population A total of 850 patients with type 2 diabetes mellitus who fulfilled the eligibility criteria were included. All 850 prescriptions were available for the final analysis. Demographic characteristics The mean age of the study participants was 55.2 ± 10.8 years, with an age range of 32–78 years. Of the 850 patients, 476 (56.0%) were men and 374 (44.0%) were women. The male-to-female ratio was approximately 1.27:1. The largest proportion of patients belonged to the age group of 51–60 years, accounting for 306 (36.0%) participants. A further 255 (30.0%) patients were older than 60 years. Table 1. Demographic characteristics of the study participants Characteristic Number of patients Percentage Sex Male 476 56.0 Female 374 44.0 Age group ≤40 years 85 10.0 41–50 years 204 24.0 51–60 years 306 36.0 >60 years 255 30.0 Total 850 100.0 Duration of diabetes The duration of diabetes was less than five years in 332 (39.1%) patients. A total of 298 (35.1%) patients had diabetes for 5–10 years, while 220 (25.9%) had been diagnosed for more than ten years. Table 2. Distribution according to duration of diabetes Duration of diabetes Number of patients Percentage <5 years 332 39.1 5–10 years 298 35.1 >10 years 220 25.9 Total 850 100.0 Associated comorbidities At least one associated comorbidity was documented in 527 (62.0%) patients. Hypertension was the most common associated condition and was documented in 400 (47.1%) patients. Dyslipidaemia was present in 179 (21.1%), ischaemic heart disease in 68 (8.0%) and chronic kidney disease in 43 (5.1%). Individual patients could have more than one comorbidity. Table 3. Associated comorbidities among the study participants Associated condition Number of patients Percentage Hypertension 400 47.1 Dyslipidaemia 179 21.1 Ischaemic heart disease 68 8.0 Chronic kidney disease 43 5.1 No documented comorbidity 323 38.0 Percentages do not total 100 because some patients had more than one comorbidity. Pattern of antidiabetic therapy Monotherapy was prescribed to 323 (38.0%) patients. Dual therapy was prescribed to 366 (43.1%), while 161 (18.9%) received triple therapy. Overall, 527 (62.0%) patients were receiving two or more active antidiabetic agents. Table 4. Distribution according to intensity of antidiabetic therapy Treatment pattern Number of patients Percentage Monotherapy 323 38.0 Dual therapy 366 43.1 Triple therapy 161 18.9 Total 850 100.0 Utilization of individual antidiabetic medicines A total of 1,538 active antidiabetic drug items were prescribed to the 850 patients. The average number of antidiabetic agents per prescription was therefore 1.81. Metformin was the most frequently prescribed antidiabetic medicine and was received by 757 (89.1%) patients. Glimepiride was the second most frequently prescribed medicine and was received by 426 (50.1%) patients. Pioglitazone was prescribed to 127 (14.9%) patients, insulin to 125 (14.7%) and sitagliptin to 103 (12.1%). Table 5. Utilization of individual antidiabetic medicines Antidiabetic medicine Patients receiving medicine, n (%) Percentage of 1,538 drug items Metformin 757 (89.1) 49.2 Glimepiride 426 (50.1) 27.7 Pioglitazone 127 (14.9) 8.3 Insulin preparations 125 (14.7) 8.1 Sitagliptin 103 (12.1) 6.7 Total active drug items - 100.0 Percentages calculated according to the number of patients exceed 100 because patients receiving combination therapy were prescribed more than one antidiabetic medicine. Specific treatment regimens Metformin monotherapy was the most frequently prescribed single-agent regimen and was used in 247 (29.1%) patients. Among dual-drug regimens, metformin plus glimepiride was the most common combination and was prescribed to 221 (26.0%) patients. Among triple-drug regimens, metformin plus glimepiride plus pioglitazone was the most frequently prescribed combination and was used in 77 (9.1%) patients. Table 6. Distribution of specific antidiabetic treatment regimens Treatment regimen Number of patients Percentage Monotherapy Metformin 247 29.1 Glimepiride 34 4.0 Insulin 42 4.9 Dual therapy Metformin + glimepiride 221 26.0 Metformin + sitagliptin 60 7.1 Metformin + pioglitazone 43 5.1 Metformin + insulin 25 2.9 Glimepiride + insulin 17 2.0 Triple therapy Metformin + glimepiride + pioglitazone 77 9.1 Metformin + glimepiride + sitagliptin 43 5.1 Metformin + glimepiride + insulin 34 4.0 Metformin + pioglitazone + insulin 7 0.8 Total 850 100.0 Utilization of insulin Insulin was prescribed to 125 (14.7%) patients. Of the patients receiving insulin, 42 received insulin as monotherapy and 83 received insulin with one or more oral antidiabetic medicines. The insulin-containing combination regimens were: • metformin plus insulin in 25 patients; • glimepiride plus insulin in 17 patients; • metformin plus glimepiride plus insulin in 34 patients; and • metformin plus pioglitazone plus insulin in seven patients. Table 7. Pattern of insulin utilization Insulin treatment pattern Number of patients Percentage of insulin users Insulin monotherapy 42 33.6 Insulin with one oral antidiabetic agent 42 33.6 Insulin with two oral antidiabetic agents 41 32.8 Total insulin users 125 100.0 Fixed-dose combinations Fixed-dose combinations were prescribed to 332 (39.1%) patients. The most frequently prescribed fixed-dose combination was metformin plus glimepiride. Some patients receiving combination therapy were prescribed the medicines as separate formulations rather than as a fixed-dose product. Generic and brand-name prescribing Of the 1,538 active antidiabetic drug items, 586 (38.1%) were prescribed by generic name and 952 (61.9%) were prescribed by brand name. Table 8. Drug-utilization indicators Drug-utilization indicator Result Total prescriptions evaluated 850 Total active antidiabetic drug items 1,538 Average antidiabetic agents per prescription 1.81 Mean total medicines per prescription 3.42 ± 1.28 Patients receiving monotherapy 323 (38.0%) Patients receiving dual therapy 366 (43.1%) Patients receiving triple therapy 161 (18.9%) Patients receiving two or more antidiabetic agents 527 (62.0%) Prescriptions containing insulin 125 (14.7%) Prescriptions containing a fixed-dose combination 332 (39.1%) Antidiabetic drug items prescribed by generic name 586 (38.1%) Antidiabetic drug items prescribed by brand name 952 (61.9%) Patients receiving metformin 757 (89.1%) Duration of diabetes and intensity of treatment The use of multiple antidiabetic medicines increased with the duration of diabetes. Among the 332 patients with diabetes for less than five years, 204 (61.4%) were receiving monotherapy and only 17 (5.1%) were receiving triple therapy. Among the 220 patients who had diabetes for more than ten years, only 25 (11.4%) were receiving monotherapy, whereas 93 (42.3%) were receiving triple therapy. Table 9. Association between duration of diabetes and treatment intensity Duration of diabetes Monotherapy Dual therapy Triple therapy Total <5 years 204 111 17 332 5–10 years 94 153 51 298 >10 years 25 102 93 220 Total 323 366 161 850 There was a statistically significant association between duration of diabetes and treatment intensity: χ²=202.05; degrees of freedom=4; p<0.001. Patients with a longer duration of diabetes were significantly more likely to receive dual or triple therapy.

The present study evaluated the utilization pattern of antidiabetic medicines among 850 patients with type 2 diabetes mellitus attending a tertiary care teaching hospital. The principal findings were the predominance of metformin-based treatment, frequent use of combination therapy, substantial utilization of glimepiride, moderate use of fixed-dose combinations and comparatively low prescribing by generic name. Demographic pattern The mean age of the study participants was 55.2 ± 10.8 years. Two-thirds of the patients were older than 50 years, and the largest proportion belonged to the age group of 51–60 years. The predominance of middle-aged and older adults is consistent with the natural history of type 2 diabetes mellitus. Insulin resistance, reduced beta-cell reserve, reduced physical activity and increasing adiposity contribute to the higher occurrence of type 2 diabetes with advancing age. Agarwal et al. also evaluated antidiabetic prescribing in an adult population attending a tertiary-care teaching hospital and observed that the burden of diabetes and requirement for treatment were substantial among middle-aged and older adults.¹⁰ Das et al. similarly reported age-related differences in the prevalence and management of type 2 diabetes in a South Indian hospital population.¹¹ Men constituted 56.0% of the study population, while women constituted 44.0%. Similar male predominance has been reported in some hospital-based drug-utilization studies. However, the sex distribution in a hospital population may be affected by healthcare access, referral patterns and health-seeking behaviour and should not be interpreted as a direct measure of community prevalence. Comorbidities At least one associated comorbidity was documented in 62.0% of patients. Hypertension was the most common comorbidity and was present in 47.1%, followed by dyslipidaemia in 21.1%. The coexistence of hypertension and dyslipidaemia with type 2 diabetes is clinically important because these conditions increase cardiovascular risk. Comprehensive diabetes management should therefore include appropriate evaluation and treatment of blood pressure, lipid abnormalities, smoking and other cardiovascular risk factors. Das et al. reported a substantial burden of cardiovascular comorbidities among patients with type 2 diabetes and emphasized that medicine utilization in diabetes frequently extends beyond glucose-lowering therapy.¹¹ The mean total number of medicines per prescription in the present study was greater than the number of antidiabetic medicines, reflecting the need to treat associated chronic conditions. Monotherapy and combination therapy Monotherapy was prescribed to 38.0% of patients, while 62.0% received two or more antidiabetic medicines. Dual therapy was the most common treatment category and was prescribed to 43.1% of the study population. The frequent use of combination therapy is consistent with the progressive nature of type 2 diabetes mellitus. A single pharmacological agent may be sufficient in the early stages of the disease, particularly when hyperglycaemia is mild and lifestyle modification is effective. However, progressive beta-cell dysfunction frequently results in loss of glycaemic control and the need for additional treatment. Sultana et al. reported frequent use of combination oral hypoglycaemic therapy in an Indian university teaching hospital.⁶ Abdi et al. also observed the use of multiple antihyperglycaemic medicines among patients treated in a South Indian tertiary-care hospital.⁷ Combination therapy may provide greater glucose reduction by targeting different pathophysiological mechanisms. Nevertheless, the addition of medicines may increase cost, treatment complexity and the risk of adverse effects. Treatment escalation should therefore be individualized and supported by clinical and laboratory assessment. Metformin utilization Metformin was the most frequently prescribed antidiabetic medicine and was used in 89.1% of patients. It accounted for 49.2% of all active antidiabetic drug items. Metformin monotherapy was prescribed to 29.1% of all patients. Metformin was also included in most dual- and triple-drug regimens. The high utilization of metformin is consistent with the recommendations available during the study period. The 2015 American Diabetes Association guidance and the joint American Diabetes Association/European Association for the Study of Diabetes position statement recommended metformin as the preferred initial pharmacological treatment for most patients with type 2 diabetes mellitus, unless contraindicated or not tolerated.⁴,⁵ The widespread use of metformin is supported by its glucose-lowering efficacy, low intrinsic risk of hypoglycaemia, weight neutrality or modest weight reduction, extensive clinical experience and comparatively low cost. The UK Prospective Diabetes Study demonstrated favourable clinical outcomes with metformin among overweight patients with newly diagnosed type 2 diabetes mellitus.¹² Metformin was associated with a reduction in diabetes-related outcomes and caused less weight gain and fewer hypoglycaemic episodes than insulin or sulfonylurea-based intensive treatment. Nandy et al. specifically assessed metformin use in a tertiary-care hospital in eastern India and documented the central role of metformin in both single-drug and combination regimens.⁸ Agarwal et al. also reported frequent metformin use in a tertiary-care prescribing study.¹⁰ Although metformin was prescribed to most participants in the present study, it was not used in every patient. Possible reasons for non-use include intolerance, gastrointestinal adverse effects, renal impairment, contraindications, previous treatment response or the need for insulin-based treatment. Sulfonylurea utilization Glimepiride was prescribed to 50.1% of patients and was the second most frequently used antidiabetic medicine. Sulfonylureas were widely used during the study period because of their effective glucose-lowering action, oral administration, rapid onset of action, availability in combination products and relatively low cost. Glimepiride was commonly selected because of familiarity among prescribers and its availability in several strengths and fixed-dose combinations. The principal limitations of sulfonylureas are the risks of hypoglycaemia and weight gain. These risks may be more important among older adults, patients with irregular food intake and patients with renal or hepatic impairment. The most common dual-drug regimen in the present study was metformin plus glimepiride, prescribed to 26.0% of the patients. This combination uses agents with complementary mechanisms: metformin primarily reduces hepatic glucose production and improves insulin sensitivity, whereas glimepiride increases pancreatic insulin secretion. Sultana et al., Nandy et al. and Agarwal et al. also documented frequent use of metformin–sulfonylurea combinations in Indian clinical practice.⁶,⁸,¹⁰ Pioglitazone utilization Pioglitazone was prescribed to 14.9% of patients. It was used in both dual- and triple-drug regimens. Pioglitazone improves insulin sensitivity and can provide effective glucose lowering. However, its use may be limited by weight gain, oedema, risk of worsening heart failure and concerns regarding fractures and other adverse effects. The relatively moderate use of pioglitazone in the present study may reflect greater caution in patients with cardiovascular disease, fluid retention or other relevant risk factors. The most common triple-drug regimen was metformin plus glimepiride plus pioglitazone. This combination was prescribed to 9.1% of the total study population. Dipeptidyl peptidase-4 inhibitor utilization Sitagliptin was prescribed to 12.1% of patients. Dipeptidyl peptidase-4 inhibitors offered potential advantages such as oral administration, weight neutrality and a low intrinsic risk of hypoglycaemia when used without insulin or a sulfonylurea. However, these medicines were more expensive than metformin and conventional sulfonylureas during the study period. The relatively limited use of sitagliptin may therefore reflect cost considerations, medicine availability and prescriber familiarity. Insulin utilization Insulin was prescribed to 125 patients, representing 14.7% of the study population. Approximately one-third of insulin users received insulin alone, while the remaining patients received insulin with one or more oral medicines. Insulin may be required in patients with marked or symptomatic hyperglycaemia, inadequate response to oral treatment, advanced beta-cell failure, contraindications to oral medicines, acute illness or pregnancy. The present study excluded gestational diabetes, and insulin use was assessed only among patients with type 2 diabetes mellitus. The comparatively lower frequency of insulin use may reflect the outpatient nature of the study population. Barriers to insulin initiation may include fear of injections, concerns regarding hypoglycaemia, need for glucose monitoring, perceived treatment complexity, social misconceptions and cost. Abdi et al. observed that insulin use was common among hospitalized patients with comorbidities or inadequate response to oral treatment.⁷ Indian consensus recommendations available in 2015 emphasized appropriate initiation and intensification of insulin when oral treatment was inadequate.¹⁵ Duration of diabetes and treatment intensity A statistically significant association was observed between duration of diabetes and treatment intensity. Among patients with diabetes for less than five years, 61.4% received monotherapy and only 5.1% received triple therapy. In contrast, among patients with diabetes for more than ten years, only 11.4% received monotherapy and 42.3% received triple therapy. This pattern is clinically plausible because type 2 diabetes is characterized by progressive deterioration of beta-cell function. Over time, patients who initially respond to lifestyle modification and a single medicine may require additional oral agents or insulin to maintain glycaemic control. The UK Prospective Diabetes Study demonstrated the progressive nature of type 2 diabetes and the frequent requirement for treatment intensification over time.¹³ Long-term follow-up further showed that early glycaemic management may have sustained benefits, although treatment usually becomes more complex as the disease progresses.¹⁴ Fixed-dose combinations Fixed-dose combinations were prescribed to 39.1% of patients. The most frequently used fixed-dose combination was metformin plus glimepiride. Fixed-dose combinations may reduce pill burden, simplify dosing and improve convenience. These advantages may be particularly relevant in patients receiving several medicines for diabetes and associated conditions. However, fixed-dose combinations also have limitations. They reduce flexibility in adjusting the dose of individual components, may expose a patient to a medicine that is not required and can complicate identification of the medicine responsible for an adverse reaction. Fixed-dose combinations should therefore be selected only when each component and its dose are appropriate for the individual patient. Generic prescribing Only 38.1% of the antidiabetic drug items were prescribed by generic name, while 61.9% were prescribed by brand name. The relatively low rate of generic prescribing indicates an important opportunity for improving rational and cost-conscious medicine use. Diabetes requires long-term treatment, and the cumulative financial burden of medicines can affect adherence. Generic prescribing improves transparency and may reduce treatment costs when quality-assured generic medicines are available. However, changes in prescribing practice must be supported by reliable procurement, quality assurance, medicine availability and prescriber confidence. Acharya et al. demonstrated substantial variation in the cost of antidiabetic treatment and emphasized the importance of rational medicine selection and adherence to treatment guidance.⁹ Average number of medicines The average number of active antidiabetic agents per prescription was 1.81. The mean total number of medicines per prescription, including treatment for comorbidities, was 3.42 ± 1.28. The difference between these values reflects the high prevalence of hypertension, dyslipidaemia and cardiovascular disease among patients with type 2 diabetes mellitus. Although the use of several medicines may be clinically justified, polypharmacy can increase the risk of adverse reactions, drug interactions, treatment confusion and non-adherence. Periodic medication review is therefore important, particularly among older patients and those with multiple comorbidities. Implications for clinical practice The findings indicate that metformin-based therapy was the foundation of type 2 diabetes management at the study hospital. The prescribing pattern was broadly consistent with the therapeutic recommendations available during the study period. However, the findings also identify areas requiring attention: 1. Generic prescribing should be increased. 2. The appropriateness of fixed-dose combinations should be reviewed periodically. 3. Patients receiving sulfonylureas or insulin should receive counselling regarding hypoglycaemia. 4. Treatment should be intensified promptly when glycaemic targets are not achieved. 5. Renal function, cardiovascular status, body weight and hypoglycaemia risk should be considered when selecting treatment. 6. Prescription audits and feedback should be conducted regularly. Strengths of the Study The principal strengths of the study were: 1. Inclusion of a relatively large sample of 850 patients. 2. Prospective collection of prescription information over one year. 3. Evaluation of individual medicines as well as specific treatment combinations. 4. Assessment of insulin and fixed-dose combination utilization. 5. Evaluation of generic prescribing. 6. Statistical assessment of the relationship between disease duration and treatment intensity. Limitations • The findings should be interpreted in view of several limitations. • First, this was a single-centre study conducted in a tertiary-care teaching hospital. The prescribing pattern may not represent primary-care centres, private clinics or hospitals in other geographical regions. • Second, the study evaluated prescriptions at a defined point and did not prospectively assess changes in treatment over subsequent visits. • Third, medication adherence was not measured. The presence of a medicine on a prescription does not confirm that the patient obtained or regularly consumed it. • Fourth, adverse drug reactions and hypoglycaemic episodes were not systematically evaluated. • Fifth, detailed information regarding renal function, hepatic function, previous treatment failure and contraindications was not available for every participant. • Sixth, treatment cost was not calculated directly from patient bills or pharmacy prices. • Seventh, the study focused primarily on prescribing patterns. It was not designed to determine the comparative effectiveness of individual medicines or combinations.

• The present drug-utilization study involving 850 patients demonstrated that metformin was the most frequently prescribed antidiabetic medicine, followed by glimepiride. • Metformin monotherapy was the most common single-drug regimen, while metformin plus glimepiride was the predominant dual-drug combination. Combination therapy was more common than monotherapy, with 62.0% of patients receiving two or more active antidiabetic agents. • The intensity of antidiabetic treatment increased significantly with the duration of diabetes. Patients with a longer duration of disease were considerably more likely to receive dual or triple therapy, reflecting the progressive nature of type 2 diabetes mellitus. • Insulin was prescribed to 14.7% of patients, and fixed-dose combinations were used in 39.1%. Only 38.1% of antidiabetic drug items were prescribed by generic name. • Regular prescription auditing, individualized treatment selection, appropriate use of fixed-dose combinations and greater generic prescribing may improve the rationality, safety and affordability of type 2 diabetes management. Recommendations 1. Periodic drug-utilization studies should be undertaken to monitor changes in antidiabetic prescribing. 2. Metformin should continue to be used as foundational therapy when clinically appropriate and not contraindicated. 3. Treatment escalation should be based on glycaemic status, duration of diabetes, comorbidities and patient-specific risk factors. 4. Insulin should not be delayed when clinically indicated. 5. Patients receiving insulin or sulfonylureas should be counselled about prevention, recognition and management of hypoglycaemia. 6. Fixed-dose combinations should be used only when the dose of each component is suitable for the patient. 7. Generic prescribing should be encouraged to improve affordability. 8. Prescribers should periodically review all medicines to reduce unnecessary polypharmacy. 9. Future studies should include treatment cost, adherence, adverse reactions and longitudinal glycaemic outcomes. 10. Multicentre studies should be conducted to determine whether the prescribing pattern is consistent across different healthcare settings.

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