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A double-blind, randomized trial, including frequent patient–physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study
- Source :
- Vascular Health and Risk Management, Vol 2014, Iss default, Pp 319-326 (2014)
- Publication Year :
- 2014
- Publisher :
- Dove Medical Press, 2014.
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Abstract
- Mohamed Hassanein,1 Khalifa Abdallah,2 Anja Schweizer31Betsi Cadwaladr University Health Board, Wales, United Kingdom; 2Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt; 3Global Medical Affairs, Novartis Pharma AG, Basel, SwitzerlandBackground: Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial.Clinical Trials Identifier: NCT01758380.Methods: This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA1c and weight were analyzed before and after Ramadan.Results: The proportion of patients reporting confirmed (
- Subjects :
- Diseases of the circulatory (Cardiovascular) system
RC666-701
Subjects
Details
- Language :
- English
- ISSN :
- 11782048
- Volume :
- 2014
- Issue :
- default
- Database :
- Directory of Open Access Journals
- Journal :
- Vascular Health and Risk Management
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.7f93bf29c7894b959c3529a203681d64
- Document Type :
- article