A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Phase 3 Completed 650 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Timeline

Start: 2015-10-20
Primary completion: 2017-05-08
Completion: 2017-11-10

Publications

Vilsboll T, Ekholm E, Johnsson E, Dronamraju N, Jabbour S, Lind M. Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial. Diabetes Care. 2019 Aug;42(8):1464-1472. doi: 10.2337/dc18-1988. Epub 2019 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral
Comparator	insulin glargine	Protein / enzyme biologic	—	—
Background	Metformin	Small molecule	1500 mg	Oral
Background	Metformin	Small molecule	2500 mg	Oral

A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Summary

Timeline

Publications

Drugs

Indications