18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.

Timeline

Start

2008-04

Primary completion

2009-03

Completion

2009-03

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority or other test); Saxa + Met vs Sita + Met; Mean Difference (Net) 0.09 (95% CI -0.01 to 0.20) reads as missed primary endpoint NCT00666458 ↗

release “ONGLYZA ™ (saxagliptin) 5 mg per day achieved the primary objective of demonstrating non-inferiority compared to the addition of treatment with JANUVIA ® (sitagliptin)” reads as met primary endpoint bms.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	—	Oral
Comparator	Sitagliptin	Small molecule	—	Oral

Indications