Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

Summary

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Timeline

Start

2008-04

Primary completion

2009-11

Completion

2010-05

Outcome

Met primary endpoint

paper placebo versus dapagliflozin 2.5/5/10 mg groups were -0.13 versus -0.58, -0.63, -0.82 %, respectively (all p < 0.0001 vs. placebo by Dunnett's procedure). PMID 23529567 ↗

release “the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c)” astrazeneca.com ↗

Publications

• Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
• Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German.
• Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	2.5 mg	Oral
Subject	Dapagliflozin	Small molecule	5 mg	Oral
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Background	Glimepiride	Small molecule	2.5 mg	Oral
Background	Glimepiride	Small molecule	5 mg	Oral
Background	Glimepiride	Small molecule	10 mg	Oral
Background	Metformin	Small molecule	—	Oral
Background	Pioglitazone	Small molecule	—	Oral
Background	Rosiglitazone	Small molecule	—	Oral

Indications