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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3541110 | PMC |
| http://dx.doi.org/10.1186/1758-5996-4-36 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Significance of adding chemotherapy to radiotherapy in the treatment of T2N0 glottic cancer.
Jpn J Clin Oncol
January 2025
Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University, School of Medicine, Yokohama, Japan.
The prognosis for T2N0 glottic squamous cell carcinoma (SCC) is generally favorable, with a 5-year overall survival rate of 79%-96% achieved with radiotherapy (RT), the standard nonsurgical treatment for this condition. However, the local control rate for T2N0 glottic SCC treated with RT remains suboptimal, with a 5-year local control rate of only 65%-80%. Local residual disease or recurrence following RT for T2N0 glottic SCC often leads to difficulties in laryngeal preservation.
View Article and Find Full Text PDFHow likely is it that a virus or bacteria is causing a patient's symptoms? A new approach to interpret the outcome from multi-pathogen PCR.
Infect Dis (Lond)
January 2025
Department of Epidemiology and Biostatistics, College of Public Health, University of Georgia, Athens, GA, USA.
Background: Whether a detected virus or bacteria is a pathogen that may require treatment, or is merely a commensal 'passenger', remains confusing for many infections. This confusion is likely to increase with the wider use of multi-pathogen PCR.
Objectives: To propose a new statistical procedure to analyse and present data from case-control studies clarifying the probability of causality.
Point-of-care ultrasound in the diagnosis of hepatic gas gangrene.
J Ultrasound
January 2025
Argentinian Critical Care Ultrasonography Association (ASARUC), Buenos Aires, Argentina.
Hepatic gas gangrene (HGG) is a rare but life-threatening condition typically caused by anaerobic bacteria such as Clostridium perfringens, though Gram-negative bacteria like Escherichia coli and Klebsiella species have also been implicated. Traditionally diagnosed via computed tomography (CT), point-of-care ultrasound (POCUS) has emerged as a valuable tool in critical care settings for its non-invasive, bedside utility. We report the case of a 51-year-old female with choledochal syndrome secondary to cholangiocarcinoma who developed HGG following left extended hepatectomy and biliary reconstruction.
View Article and Find Full Text PDFChanges in cerebrovascular reactivity as a marker of cognitive impairment risk: a transcranial Doppler study.
J Ultrasound
January 2025
Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, University Hospital and Health Services of Trieste, ASUGI, University of Trieste, Strada di Fiume, 447, 34149, Trieste, Italy.
Introduction: Post-stroke cognitive impairment (PSCI) and dementia affect short- and long-term outcome after stroke and can persist even after recover from a physical handicap. The process underlying PSCI is not yet fully understood. Transcranial Doppler ultrasound (TCD) is a feasible method to investigate cerebrovascular aging or dementia, through the pulsatility index (PI), the cerebrovascular reactivity (e.
View Article and Find Full Text PDFShould adrenal incidentaloma patients be evaluated for muscle mass, function, and quality? A cross-sectional study.
Endocrine
January 2025
Department of Endocrinology and Metabolic Diseases, Manisa Celal Bayar University Hospital, Manisa, Turkey.
Purpose: Our study evaluated skeletal muscle mass, function and quality among mild autonomous cortisol secretion (MACS) patients and non-functioning adrenal incidentaloma (NFAI) patients in comparison with the control group without adrenal mass.
Methods: 63 NFAI (49 female, 14 male) and 31 MACS (24 female, 7 male) patients were included in the study. As the control group, 44 patients (31 women, 13 men) who were known to have no radiological adrenal pathology on computed tomography or magnetic resonance imaging performed for other reasons were selected.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!