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

NCT02419612 ↗

Phase 3 Completed 444 enrolled AstraZeneca

RandomizedParallel-groupTriple-blindTreatment

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

Outcome

Met primary endpoint

paper Adjusted mean change from baseline in HbA1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P <0.001). PMID 32052516 ↗

registry analysis (superiority test); Dapagliflozin 10mg and Saxagliptin 5mg vs Titrated Glimepiride; p <0.001; Least Squares (LS) Mean Difference -0.37 NCT02419612 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Subject	Glimepiride	Small molecule	1 mg	Oral
Subject	Glimepiride	Small molecule	2 mg	Oral
Subject	Glimepiride	Small molecule	3 mg	Oral
Subject	Glimepiride	Small molecule	4 mg	Oral
Subject	Glimepiride	Small molecule	6 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral