PMID- 22828124 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20130111 LR - 20211021 IS - 1758-5996 (Electronic) IS - 1758-5996 (Linking) VI - 4 IP - 1 DP - 2012 Jul 24 TI - The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naive patients with type 2 diabetes mellitus: a randomized controlled trial. PG - 36 LID - 10.1186/1758-5996-4-36 [doi] AB - BACKGROUND: The aim of this study was to assess efficacy and safety of saxagliptin monotherapy for up to 76 weeks in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, with main efficacy assessment at 24 weeks. METHODS: 365 treatment-naive patients with T2DM (HbA1c 7.0%-10.0%) 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 >/=7%, and all unrescued placebo patients began blinded metformin 500 mg/day. Rescue with open-label metformin was available for patients with inadequate glycemic control. RESULTS: 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]). CONCLUSIONS: In treatment-naive 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00316082. FAU - Frederich, Robert AU - Frederich R AD - Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA. bob.frederich@bms.com. FAU - McNeill, Robert AU - McNeill R FAU - Berglind, Niklas AU - Berglind N FAU - Fleming, Douglas AU - Fleming D FAU - Chen, Roland AU - Chen R LA - eng SI - ClinicalTrials.gov/NCT00316082 PT - Journal Article DEP - 20120724 PL - England TA - Diabetol Metab Syndr JT - Diabetology & metabolic syndrome JID - 101488958 PMC - PMC3541110 EDAT- 2012/07/26 06:00 MHDA- 2012/07/26 06:01 PMCR- 2012/07/24 CRDT- 2012/07/26 06:00 PHST- 2012/02/24 00:00 [received] PHST- 2012/06/23 00:00 [accepted] PHST- 2012/07/26 06:00 [entrez] PHST- 2012/07/26 06:00 [pubmed] PHST- 2012/07/26 06:01 [medline] PHST- 2012/07/24 00:00 [pmc-release] AID - 1758-5996-4-36 [pii] AID - 10.1186/1758-5996-4-36 [doi] PST - epublish SO - Diabetol Metab Syndr. 2012 Jul 24;4(1):36. doi: 10.1186/1758-5996-4-36.