Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes

Abstract: Objective
To compare the efficacy and safety of dapagliflozin and dapagliflozin plus saxagliptin vs glimepiride as add-on to metformin in patients with type 2 diabetes.

Research design and methods
This 52-week, multicentre, double-blind, active-controlled study (NCT02471404) randomized (1:1:1) patients (n = 939; HbA1c 7.5%-10.5%) on metformin monotherapy (≥1500 mg/day) to add-on dapagliflozin 10 mg, dapagliflozin 10 mg plus saxagliptin 5 mg, or glimepiride 1 to 6 mg (titrated). The primary efficacy end point was change in HbA1c from baseline to Week 52.

Results
Baseline mean age, diabetes duration and HbA1c were 58.4 years, 7.0 years and 8.3%, respectively. Adjusted mean HbA1c change from baseline was −1.20% with dapagliflozin plus saxagliptin and −0.82% with dapagliflozin, vs −0.99% with glimepiride (mean dose at Week 52, 4.6 mg). Changes in body weight (−3.2 kg and −3.5 kg vs +1.8 kg) and systolic blood pressure (SBP; −6.4 mm Hg and −5.6 mm Hg vs −1.6 mm Hg) were significantly greater with dapagliflozin plus saxagliptin and dapagliflozin than with glimepiride. FPG decreased significantly with dapagliflozin plus saxagliptin compared with glimepiride (−2.1 mmol/L vs −1.5 mmol/L) and was similar with dapagliflozin (−1.6 mmol/L) compared with glimepiride. Confirmed incidence of hypoglycaemia was lower with dapagliflozin regimens than with glimepiride (0 and 1 vs 13 patients) and fewer patients required rescue. Genital infections were more frequent with dapagliflozin; other AE profiles were similar.

Conclusions
Dapagliflozin, saxagliptin and metformin improved glycaemic control compared with glimepiride plus metformin; add-on of dapagliflozin alone showed efficacy similar to that of glimepiride. Both dapagliflozin regimens decreased body weight and SBP, with a lower incidence of hypoglycaemia compared with glimepiride

Object Details

• Location: Deutsche Nationalbibliothek Frankfurt am Main
• Extent: Online-Ressource
• Language: Englisch
• Notes: Diabetes, obesity and metabolism. - 20, 11 (2018) , 2598-2607, ISSN: 1462-8902

Classification and Topics

• Classification: Medizin, Gesundheit

Contributors, Places and Time

• Event: Veröffentlichung
• (where): Freiburg
• (who): Universität
• (when): 2019
• Creator: Müller-Wieland, Dirk ; Kellerer, Monika ; Cypryk, Katarzyna ; Skripova, Dasa ; Rohwedder, Katja ; Johnsson, Eva ; Garcia-Sanchez, Ricardo ; Kurlyandskaya, Raisa ; Sjöström, C. David ; Jacob, Stephan ; Seufert, Jochen ; Dronamraju, Nalina ; Csomós, Katalin
• Contributor: Universitätsklinikum Freiburg. Klinik für Innere Medizin II

Further information

• DOI: 10.1111/dom.13437
• URN: urn:nbn:de:bsz:25-freidok-1464649
• Rights: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
• Last update: 15.08.2025, 7:27 AM CEST