Sitagliptin, Metformin and Glimepiride Fixed‐Dose Combination Compared to Co‐Administration of Metformin and High‐Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double‐Blind, Double‐Dummy, Phase 3 Clinical Study

Sahay, R; Gowda, A; Singh, MK; Rao, AG; Duraisamy, R; Gangwani, D; Shukla, J; Agarwal, V; Patil, SS; C, A; K N, SB; Palawat, A; Gofne, SK; Sahoo, AK; Rai, PK; Shaikh, R; Saha, S; Patil, D; Ghadge, P; Patel, P; Lakhwani, L; Mehta, S; Joglekar, S

doi:10.1111/dom.70778

Type 2 & other diabetes

Sitagliptin, Metformin and Glimepiride Fixed‐Dose Combination Compared to Co‐Administration of Metformin and High‐Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double‐Blind, Double‐Dummy, Phase 3 Clinical Study

Diabetes Obes MetabPublished 3 May 2026Randomised controlled trial

Primary result · Change in HbA1c from baselineResultEstimated treatment difference −0.51 95% CI −0.69 to −0.33

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Authors' conclusion

The triple FDC was superior to co-administered metformin and high-dose glimepiride for achieving glycaemic control and was well tolerated in Indian patients with T2D.

Study context

Population: Indian adults with T2D and HbA1c 8%-11% despite metformin and glimepiriderandomised 1:1
Participants: 190 vs 202

Comparison: Triple fixed-dose combination (FDC) of sitagliptin, metformin and glimepiride vs co-administered metformin and high-dose glimepiride
SITA + MET + GLIMn = 190
Co-administrationn = 202reference
Primary endpoint: Change in HbA1c from baseline
Follow-up: Week 16

Methodological detailsphase 3, double-blind, double-dummy, SITA + MET + GLIM patients could continue for a 12-week open-label period

Phase 3
Double-blind
Double-dummy
SITA + MET + GLIM patients could continue for a 12-week open-label period

Primary result

As reported in the abstract

Estimated treatment difference

−0.51

95% CI −0.69 to −0.33

P < 0.0001

Change by group

SITA + MET + GLIM

−1.79

least squares mean · SE 0.07 · %

Co-administration

−1.27

least squares mean · SE 0.06 · %

SITA + MET + GLIMvs Co-administration

estimated treatment difference −0.51 (95% CI −0.69 to −0.33); P < 0.0001

Further findings

HbA1c below 7% · Week 16

P < 0.0001

SITA + MET + GLIM32.1%

Co-administration12.6%

Safety

Adverse events

SITA + MET + GLIM13.2%

Co-administration14.9%

Original publication

Sitagliptin, Metformin and Glimepiride Fixed‐Dose Combination Compared to Co‐Administration of Metformin and High‐Dose Glimepiride in Indian Patients With Type 2 Diabetes: A Randomised, Double‐Blind, Double‐Dummy, Phase 3 Clinical Study. Diabetes Obes Metab. Published 3 May 2026. doi:10.1111/dom.70778

Read the original article ↗

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