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Background <p>Type 2 diabetes mellitus (T2D) is a growing global and Indian health challenge. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), increasingly used in India, are linked to higher genitourinary infection (UTI/GTI) rates in people with T2D worldwide, yet real-world evidence in India remains limited. The impact of combining SGLT2i with Dipeptidyl peptidase-4 inhibitors (DPP4i) on infection risk also requires investigation in this setting.</p> Methods <p>This multicenter, cross-sectional, observational study enrolled adults with T2D across India from June 15 to September 30, 2023. Data on UTI/GTI incidence, antidiabetic medications, demographics, and comorbidities were collected. Logistic regression and propensity score matching evaluated associations between SGLT2i, DPP4i, their combination, and UTI/GTI risk.</p> Results <p>Of 15,611 T2D patients across 42 sites, the mean age was 55.7 years (SD 12.1) and mean BMI 26.7 kg/m<sup>2</sup> (SD 4.8). Urogenital infection incidence is 11.3% (95% CI: 10.8%–11.8%), with GTI at 5.8% (95% CI: 5.4%–6.2%) and UTI at 7.1% (95% CI: 6.6%–7.4%). Females showed higher rates than males (13.3% vs. 9.7%, <i>p</i> &lt; 0.001). SGLT2i users had a significantly elevated infection rate (13.2%, 95% CI: 12.5%–13.8%) compared to non-users (7.2%, 95% CI: 6.5%–8.0%, <i>p</i> &lt; 0.001). Subjects in SGLT2i with DPP4i (no other OADs) had the lowest infection rate (4.4%, 95% CI: 2.7%–6.1%, <i>p</i> &lt; 0.001). Regression analysis (61% accuracy) revealed that SGLT2i increased infection odds by 2.89 (95% CI: 1.69–2.96, <i>p</i> &lt; 0.001), but adding DPP4i reduced it to 1.62 (95% CI: 1.36–1.92, <i>p</i> &lt; 0.001).</p> Conclusions <p>This first large-scale, real-world study in India confirms a higher UTI/GTI incidence in people with T2D on SGLT2i. Notably, combining DPP4i with SGLT2i was associated with a lower observed incidence of urogenital infections compared with SGLT2i without DPP4i. These findings are observational and require prospective validation. These results highlight the need for tailored therapeutic strategies in Indian T2D management.</p> Clinical trial number <p>not applicable</p>

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Real-world evidence of urinary tract infections and genital tract infections with sodium-glucose cotransporter-2 inhibitors (SGLT2i) alone or in combination with dipeptidyl peptidase-4 inhibitors (DPP4i) in individuals with type-2 diabetes mellitus in India

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  • 发表日期：

    2026年5月20日

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  • Nagendra Kumar Singh,
  • Akash Kumar Singh,
  • Arvind Gupta,
  • Sanjeev Ratnakar Phatak,
  • Arvind Kumar Sharma,
  • Bijay Patni,
  • Neeru Gera,
  • Shunmugavelu M,
  • Sanjay Shah,
  • Soumya Sengupta,
  • Ashish K Saxena,
  • Bharat Saboo,
  • Ajoy Tewari,
  • Prabhakar Damodar Gokhale,
  • Kiran Shah,
  • Digambar Naik,
  • Chandni Radhakrishnan,
  • SreenivasaMurthy L,
  • Surendranath Swain,
  • Ashish Gautam,
  • Meena Chhabra,
  • Arun Kumar Kedia,
  • Mohsin Aslam,
  • Aravinda Jagadeesha,
  • Lily Rodrigues,
  • Prabhat Agrawal,
  • Ripun Borpuzari,
  • Nikhil Pursnani,
  • Basab Ghosh,
  • Manohar K Nageshappa,
  • Santosh Hanumandas Malpani,
  • Harish Darla B,
  • Sudhir Chandra Jha,
  • Noni Gopal Singha,
  • Dariya S S,
  • Anubha Srivastava,
  • Raka Sheohare,
  • Sonika Lamba,
  • Panneerselvam A,
  • Manish Shrikrishna Kushe,
  • Ambrish Mithal,
  • Shashank R Joshi,
  • Banshi Saboo,
  • Rutuja Sharma,
  • Rajeev Gupta

摘要

Background

Type 2 diabetes mellitus (T2D) is a growing global and Indian health challenge. Sodium-glucose cotransporter-2 inhibitors (SGLT2i), increasingly used in India, are linked to higher genitourinary infection (UTI/GTI) rates in people with T2D worldwide, yet real-world evidence in India remains limited. The impact of combining SGLT2i with Dipeptidyl peptidase-4 inhibitors (DPP4i) on infection risk also requires investigation in this setting.

Methods

This multicenter, cross-sectional, observational study enrolled adults with T2D across India from June 15 to September 30, 2023. Data on UTI/GTI incidence, antidiabetic medications, demographics, and comorbidities were collected. Logistic regression and propensity score matching evaluated associations between SGLT2i, DPP4i, their combination, and UTI/GTI risk.

Results

Of 15,611 T2D patients across 42 sites, the mean age was 55.7 years (SD 12.1) and mean BMI 26.7 kg/m2 (SD 4.8). Urogenital infection incidence is 11.3% (95% CI: 10.8%–11.8%), with GTI at 5.8% (95% CI: 5.4%–6.2%) and UTI at 7.1% (95% CI: 6.6%–7.4%). Females showed higher rates than males (13.3% vs. 9.7%, p < 0.001). SGLT2i users had a significantly elevated infection rate (13.2%, 95% CI: 12.5%–13.8%) compared to non-users (7.2%, 95% CI: 6.5%–8.0%, p < 0.001). Subjects in SGLT2i with DPP4i (no other OADs) had the lowest infection rate (4.4%, 95% CI: 2.7%–6.1%, p < 0.001). Regression analysis (61% accuracy) revealed that SGLT2i increased infection odds by 2.89 (95% CI: 1.69–2.96, p < 0.001), but adding DPP4i reduced it to 1.62 (95% CI: 1.36–1.92, p < 0.001).

Conclusions

This first large-scale, real-world study in India confirms a higher UTI/GTI incidence in people with T2D on SGLT2i. Notably, combining DPP4i with SGLT2i was associated with a lower observed incidence of urogenital infections compared with SGLT2i without DPP4i. These findings are observational and require prospective validation. These results highlight the need for tailored therapeutic strategies in Indian T2D management.

Clinical trial number

not applicable