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Background <p>In the era of comprehensive diabetes management, fixed-dose combinations (FDCs) utilising distinct mechanisms and complementary modes of action have emerged as effective treatment options. These combinations help reduce pill burden and enhance patient compliance. This study aimed to evaluate the clinical outcomes of an FDC comprising Sitagliptin (100&#xa0;mg), Dapagliflozin (10&#xa0;mg), and Metformin (500&#xa0;mg) in managing Type 2 Diabetes Mellitus (T2DM).</p> Methods <p>This prospective observational study included T2DM patients with inadequate glycaemic control, defined as HbA1c &gt; 7%, Fasting Blood Sugar (FBS) &gt; 126&#xa0;mg/dL, and Post-prandial blood sugar (PPBS) &gt; 200&#xa0;mg/dL. Patients included had prior exposure to the fixed-dose combination and were followed prospectively. Clinical efficacy was assessed by measuring improvements in HbA1c, FBS, and PPBS parameters at 3- and 6-month post-treatment relative to baseline. Compliance was determined using the Hill-Bone medication adherence scale. Data were analysed using Student’s t-test and chi-square test at a 5% significance level.</p> Results <p>The study included 252 participants (58.3% male; 41.7% female) with a mean age of 58.5 ± 11.4 years. Most patients were older than 45 years (87.3%), and 49% were above 60 years. Hypertension (100%) and dyslipidaemia (98.5%) were highly prevalent in the study population. After six months of treatment, significant improvements were observed in glycaemic parameters. HbA1c decreased from 10.1% ± 2.3 to 6.6% ± 0.9 (<i>P</i> &lt; 0.0001), FBS from 160.1 ± 25&#xa0;mg/dl to 103.3 ± 13.99&#xa0;mg/dl (<i>P</i> &lt; 0.0001), and PPBS from 282 ± 72.9&#xa0;mg/dl to 161.6 ± 23.7&#xa0;mg/dl (<i>P</i> &lt; 0.0001). Approximately 80% of patients achieved HbA1c &lt; 7%, while target FBS and PPBS levels were achieved in 41.3% and 21% of patients, respectively.</p> <p>The incidence of genitourinary tract infections remained similar during follow-up (2.4% vs. 3.5%; P = 0.3769). Glycaemic improvements were consistent across subgroups based on diabetes duration. A mean weight reduction of 5.9 kg was observed over the study period. Good medication adherence (80–100%) was reported in 95.2% and 98% of patients at 3 and 6 months, respectively.</p> Conclusion <p>The fixed-dose combination of sitagliptin (100 mg), dapagliflozin (10 mg), and metformin (500 mg) was associated with improved glycaemic control in patients with type 2 diabetes mellitus without an increase in genitourinary infections. However, in the absence of a comparator group, these findings should be interpreted cautiously. The observed weight reduction requires further evaluation in larger, long-term studies.</p>

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Safety efficacy and treatment compliance of triple fixed dose combination dapagliflozin sitagliptin and metformin in patients with type 2 diabetes mellitus

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  • 发表日期：

    2026年6月27日

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  • Ancy Maria Monica L,
  • Arthi Maria Patricia L

摘要

Background

In the era of comprehensive diabetes management, fixed-dose combinations (FDCs) utilising distinct mechanisms and complementary modes of action have emerged as effective treatment options. These combinations help reduce pill burden and enhance patient compliance. This study aimed to evaluate the clinical outcomes of an FDC comprising Sitagliptin (100 mg), Dapagliflozin (10 mg), and Metformin (500 mg) in managing Type 2 Diabetes Mellitus (T2DM).

Methods

This prospective observational study included T2DM patients with inadequate glycaemic control, defined as HbA1c > 7%, Fasting Blood Sugar (FBS) > 126 mg/dL, and Post-prandial blood sugar (PPBS) > 200 mg/dL. Patients included had prior exposure to the fixed-dose combination and were followed prospectively. Clinical efficacy was assessed by measuring improvements in HbA1c, FBS, and PPBS parameters at 3- and 6-month post-treatment relative to baseline. Compliance was determined using the Hill-Bone medication adherence scale. Data were analysed using Student’s t-test and chi-square test at a 5% significance level.

Results

The study included 252 participants (58.3% male; 41.7% female) with a mean age of 58.5 ± 11.4 years. Most patients were older than 45 years (87.3%), and 49% were above 60 years. Hypertension (100%) and dyslipidaemia (98.5%) were highly prevalent in the study population. After six months of treatment, significant improvements were observed in glycaemic parameters. HbA1c decreased from 10.1% ± 2.3 to 6.6% ± 0.9 (P < 0.0001), FBS from 160.1 ± 25 mg/dl to 103.3 ± 13.99 mg/dl (P < 0.0001), and PPBS from 282 ± 72.9 mg/dl to 161.6 ± 23.7 mg/dl (P < 0.0001). Approximately 80% of patients achieved HbA1c < 7%, while target FBS and PPBS levels were achieved in 41.3% and 21% of patients, respectively.

The incidence of genitourinary tract infections remained similar during follow-up (2.4% vs. 3.5%; P = 0.3769). Glycaemic improvements were consistent across subgroups based on diabetes duration. A mean weight reduction of 5.9 kg was observed over the study period. Good medication adherence (80–100%) was reported in 95.2% and 98% of patients at 3 and 6 months, respectively.

Conclusion

The fixed-dose combination of sitagliptin (100 mg), dapagliflozin (10 mg), and metformin (500 mg) was associated with improved glycaemic control in patients with type 2 diabetes mellitus without an increase in genitourinary infections. However, in the absence of a comparator group, these findings should be interpreted cautiously. The observed weight reduction requires further evaluation in larger, long-term studies.