Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

Summary

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

Timeline

Start

2009-10

Primary completion

—

Completion

2010-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Saxagliptin vs Metformin Uptitration; p = 0.26; Mean Difference (Net) -0.10 (95% CI -0.26 to 0.07); ANCOVA NCT01006590 ↗

paper Although HbA(1c) reduction was not significantly different between treatment groups PMID 23020253 ↗

Publications

• Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Metformin	Small molecule	500 mg	Oral
Comparator	Metformin	Small molecule	1000 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral

Indications