Back to Journals » Vascular Health and Risk Management » Volume 10

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

Authors Hassanein M, Abdallah K, Schweizer A

Received 13 March 2014

Accepted for publication 30 April 2014

Published 28 May 2014 Volume 2014:10 Pages 319—326

DOI https://doi.org/10.2147/VHRM.S64038

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Mohamed Hassanein,1 Khalifa Abdallah,2 Anja Schweizer3

1Betsi Cadwaladr University Health Board, Wales, United Kingdom; 2Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt; 3Global Medical Affairs, Novartis Pharma AG, Basel, Switzerland

Background: 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 (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA1c was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments.
Conclusion: In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient–physician contacts, Ramadan-focused advice, a recent switch in treatment, and very well-controlled patients, which is different from what is often seen in real life.

Keywords: dipeptidyl peptidase 4, fasting, incretin, type 2 diabetes mellitus, hypoglycemia, Ramadan

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Other articles by this author:

Clinical evidence and mechanistic basis for vildagliptin's effect in combination with insulin

Schweizer A, Foley JE, Kothny W, Ahrén B

Vascular Health and Risk Management 2013, 9:57-64

Published Date: 15 February 2013

Combination treatment in the management of type 2 diabetes: focus on vildagliptin and metformin as a single tablet

Serge Halimi, Anja Schweizer, Biljana Minic, James Foley, Sylvie Dejager

Vascular Health and Risk Management 2008, 4:481-492

Published Date: 6 June 2008

Readers of this article also read:

How are patients with type 2 diabetes and renal disease monitored and managed? Insights from the observational OREDIA study

Penfornis A, Blicklé JF, Fiquet B, Quéré S, Dejager S

Vascular Health and Risk Management 2014, 10:341-352

Published Date: 13 June 2014

Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010

Bramlage P, Deutsch C, Krüger R, Wolf A, Müller P, Zwingers T, Beime B, Mengden T

Vascular Health and Risk Management 2014, 10:303-309

Published Date: 13 May 2014

Is higher body temperature beneficial in ischemic stroke patients with normal admission CT angiography of the cerebral arteries?

Kvistad CE, Khanevski A, Nacu A, Thomassen L, Waje-Andreassen U, Naess H

Vascular Health and Risk Management 2014, 10:49-54

Published Date: 21 January 2014

Clinical evidence and mechanistic basis for vildagliptin's effect in combination with insulin

Schweizer A, Foley JE, Kothny W, Ahrén B

Vascular Health and Risk Management 2013, 9:57-64

Published Date: 15 February 2013

Percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion

Lichtenberg M, Käunicke M, Hailer B

Vascular Health and Risk Management 2012, 8:283-289

Published Date: 4 May 2012

Mixed dyslipidemias in primary care patients in France

Laforest L, Ambegaonkar BM, Souchet T, Sazonov V, Van Ganse E

Vascular Health and Risk Management 2012, 8:247-254

Published Date: 19 April 2012

Absorbable stent: focus on clinical applications and benefits

Gonzalo N, Macaya C

Vascular Health and Risk Management 2012, 8:125-132

Published Date: 29 February 2012