Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3 Completed 365 enrolled AstraZeneca

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Timeline

Start: 2006-06
Primary completion: 2007-11
Completion: 2008-11

Outcome

Met primary endpoint

paper At week 24, placebo-subtracted mean HbA1c reduction from baseline (LOCF) was significantly greater in the saxagliptin treatment groups vs placebo PMID 22828124 ↗

Publications

Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Bonora E, Bryzinski B, Hirshberg B, Cook W. A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score. Nutr Metab Cardiovasc Dis. 2016 May;26(5):374-9. doi: 10.1016/j.numecd.2015.11.004. Epub 2015 Dec 1.
Frederich R, McNeill R, Berglind N, Fleming D, Chen R. The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	2.5 mg	Oral
Subject	SAXAGLIPTIN ANHYDROUS	Small molecule	5 mg	Oral
Background	Metformin	Small molecule	500 mg	Oral
Background	Metformin	Small molecule	2000 mg	Oral