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Open Access Highly Accessed Research

The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naïve patients with type 2 diabetes mellitus: a randomized controlled trial

Robert Frederich1*, Robert McNeill2, Niklas Berglind3, Douglas Fleming1 and Roland Chen1

Author Affiliations

1 Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA

2 PMG Research of Salisbury, 401 Mocksville Ave., Salisbury, NC, 28144, USA

3 AstraZeneca R&D, Kärragatan 5, 431 83, Mölndal, Sweden

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Diabetology & Metabolic Syndrome 2012, 4:36  doi:10.1186/1758-5996-4-36

Published: 24 July 2012

Abstract

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-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.

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-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 registration

ClinicalTrials.gov Identifier: NCT00316082

Keywords:
DPP-4 inhibitor; Monotherapy; Saxagliptin; Titration; Type 2 diabetes mellitus