%0 Journal Article
%T The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-na£¿ve patients with type 2 diabetes mellitus: a randomized controlled trial
%A Robert Frederich
%A Robert McNeill
%A Niklas Berglind
%A Douglas Fleming
%A Roland Chen
%J Diabetology & Metabolic Syndrome
%D 2012
%I BioMed Central
%R 10.1186/1758-5996-4-36
%X 365 treatment-na£¿ve patients with T2DM (HbA1c 7.0%¨C10.0%) were treated with saxagliptin 2.5£¿mg q.A.M., saxagliptin 2.5£¿mg q.A.M. with possible titration to saxagliptin 5£¿mg, saxagliptin 5£¿mg q.A.M., saxagliptin 5£¿mg q.P.M., or placebo. After week 24, patients in all groups were eligible for titration to saxagliptin 10£¿mg based on HbA1c ¡Ý7%, and all unrescued placebo patients began blinded metformin 500£¿mg/day. Rescue with open-label metformin was available for patients with inadequate glycemic control.At week 24, placebo-subtracted mean HbA1c reduction from baseline (LOCF) was significantly greater in the saxagliptin treatment groups vs placebo, and remained greater through week 76. Serious adverse events (AEs) and discontinuations due to AEs were similar in saxagliptin and control groups; incidence of confirmed hypoglycemia was low across all treatment groups (saxagliptin-treated, 2 [0.7]; control, 1 [1.4]).In treatment-na£¿ve patients with T2DM, saxagliptin monotherapy demonstrated statistically significant improvement in HbA1c compared with placebo at 24£¿weeks and was generally well tolerated for up to 76£¿weeks.ClinicalTrials.gov Identifier: NCT00316082After initiation of therapy, patients with type 2 diabetes mellitus (T2DM) are likely to require pharmacotherapeutic management for the remainder of their lives. Understanding the long-term efficacy and safety profiles of newer antidiabetic medications is necessary for optimizing treatment regimens over time. Incretin-based therapies, such as dipeptidyl peptidase-4 (DPP-4) inhibitors, are a class of recently developed antidiabetic agents for which long-term safety data are only now becoming available [1].Saxagliptin is a potent, selective DPP-4 inhibitor approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM [2]. As monotherapy, saxagliptin 2.5, 5, and 10£¿mg led to statistically significant improvements in glycemic indices versus placebo at week 24, and was generally well tolerat
%K DPP-4 inhibitor
%K Monotherapy
%K Saxagliptin
%K Titration
%K Type 2 diabetes mellitus
%U http://www.dmsjournal.com/content/4/1/36