A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Summary

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Timeline

Start

2015-08-14

Primary completion

2017-08-29

Completion

2019-09-18

Publications

• Frias JP, Gonzalez-Galvez G, Johnsson E, Maaske J, Testa MA, Simonson DC, Dronamraju N, Garcia-Sanchez R, Peters AL. Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial. Diabetes Obes Metab. 2020 Jul;22(7):1083-1093. doi: 10.1111/dom.13997. Epub 2020 Mar 9.

Drugs

Indications