Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial
Diabetes/Metabolism Research and Reviews,  Clinical Article

Pan CY et al. – Saxagliptin improved glycaemic control and was well tolerated in drug–naïve Asian patients with type 2 diabetes mellitus (T2DM).

Methods
  • Five hundred sixty-eight drug-naïve adult patients with T2DM and glycated haemoglobin levels (HbA1c) of 7.0–10.0% (53–86 mmol/mol) were randomized 1:1 to receive saxagliptin 5 mg daily or placebo.
  • Efficacy endpoints included changes from baseline to week 24 in HbA1c, fasting plasma glucose (FPG), post-prandial glucose area under the curve from 0 to 180 min (PPG AUC0–180), and the proportion of patients achieving HbA1c <7.0% (53 mmol/mol). Adverse events (AEs) and serious AEs (SAEs) were evaluated.

Results
  • Saxagliptin provided statistically significant adjusted mean decreases from baseline to week 24 compared with placebo, respectively, in HbA1c (-0.84% [-9 mmol/mol] versus -0.34% [-4 mmol/mol]; p < 0.0001), FPG (-0.90 versus -0.17 mmol/L; p < 0.0001), and PPG AUC0–180 (-417 versus -235 mmol • min/L; p = 0.0010).
  • A significantly greater proportion of patients achieved a therapeutic glycaemic response (HbA1c <7.0% [53 mmol/mol]) with saxagliptin (45.8%) versus placebo (28.8%; p < 0.0001).
  • The proportions of patients who experienced ≥1 AE (excluding hypoglycaemia) was 43.3% for saxagliptin and 35.6% for placebo.
  • Few patients in either treatment group experienced an SAE (2.8%, saxagliptin; 1.4%, placebo).
  • A low proportion of patients reported hypoglycaemic events (1.8%, saxagliptin; 0.7%, placebo).

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Physician Assistant

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Physician Assistant Articles

1 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 22, 2014    Clinical Article

2 Dance for Parkinson's: A new framework for research on its physical, mental, emotional, and social benefits Complementary Therapies in Medicine, June 17, 2014    Review Article

3 Omega-3 supplements for patients in chemotherapy and/or radiotherapy: A systematic review Clinical Nutrition, November 21, 2014    Clinical Article

4 Global burden of cancer attributable to high body-mass index in 2012: A population-based study The Lancet Oncology, November 26, 2014    Clinical Article

5 Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents New England Journal of Medicine, November 18, 2014    Evidence Based Medicine    Clinical Article

6 Nonobstructive coronary artery disease and risk of myocardial infarction JAMA, November 6, 2014    Evidence Based Medicine    Clinical Article

7 Treatment of syphilis: a systematic review JAMA, November 13, 2014    Review Article    Clinical Article

8 Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial The Lancet, November 26, 2014    Evidence Based Medicine    Clinical Article

9 Effects of salt substitutes on blood pressure: A meta-analysis of randomized controlled trials American Journal of Clinical Nutrition, October 31, 2014    Evidence Based Medicine    Review Article    Clinical Article

10 Bipolar disorder, affective psychosis, and schizophrenia in pregnancy and the post-partum period The Lancet, November 19, 2014    Evidence Based Medicine

11 Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial The Lancet, November 26, 2014    Clinical Article

12 Initial choice of oral glucose-lowering medication for diabetes mellitus: a patient-centered comparative effectiveness study JAMA Internal Medicine, November 14, 2014    Evidence Based Medicine    Clinical Article

13 Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the smarte-R-CHOP-14 trial of the German High-grade Non-hodgkin Lymphoma Study Group Journal of Clinical Oncology, November 26, 2014    Clinical Article

14 Early versus on-demand nasoenteric tube feeding in acute pancreatitis New England Journal of Medicine, November 26, 2014    Evidence Based Medicine    Clinical Article

15 Ventriculitis caused by primary T-cell CNS lymphoma in an immunocompetent patient Journal of Clinical Oncology, November 26, 2014

16 Long-term safety and efficacy of factor IX gene therapy in hemophilia B New England Journal of Medicine, November 26, 2014    Evidence Based Medicine    Clinical Article

17 Management of high-grade gliomas in the elderly Seminars in Radiation Oncology, October 3, 2014    Clinical Article

18 The diagnosis and management of hiatus hernia BMJ, November 14, 2014    Evidence Based Medicine    Review Article    Clinical Article

19 Statins in the elderly: an answered question Current Opinion in Cardiology, June 9, 2014    Evidence Based Medicine    Review Article    Clinical Article

20 Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: An international, double-blind, randomised, placebo-controlled trial The Lancet Oncology, November 26, 2014    Clinical Article

Indexed Journals in Physician Assistant: Advance for Physicians Assistants, American Family Physicianmore