Abstract
BackgroundThe 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.Methods365 treatment-naïve 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.ResultsAt 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]).ConclusionsIn treatment-naïve 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 registrationClinicalTrials.gov Identifier: NCT00316082
Highlights
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
Saxagliptin is a potent, selective dipeptidyl peptidase-4 (DPP-4) inhibitor approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM [2]
Hypoglycemic events were comparable between saxagliptin treatment groups and placebo, and there were no increases in weight [3]
Summary
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. 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 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]. Long-term efficacy and safety data for saxagliptin as add-on therapy to metformin [4], a sulfonylurea [5], or a thiazolidinedione [6], or as initial combination therapy with metformin [7], have been published, but long-term data have not been published for saxagliptin monotherapy at approved doses of 2.5 and 5 mg
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