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

Hassanein, Mohamed; Abdallah, Khalifa; Schweizer, Anja
May 2014
Vascular Health & Risk Management;2014, Vol. 10, p319
Academic Journal
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.


Related Articles

  • Gliclazide/metformin: Recurrent hypoglycaemia: case report.  // Reactions Weekly;Nov2013, Issue 1477, p19 

    An abstract of the article "Hypoglycaemia begets hypoglycaemia," by A. Arora is presented.

  • Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes. Balijepalli, Chakrapani; Druyts, Eric; Siliman, Gaye; Joffres, Michel; Thorlund, Kristian; Mills, Edward J. // Clinical Epidemiology;May2017, Vol. 9, p291 

    Objective: To understand the severity and potential impact of heterogeneity in definitions of hypoglycemia used in diabetes research, we aimed to review the hypoglycemia definitions adopted in randomized controlled trials (RCTs). Methods: We reviewed 109 RCTs included in the Canadian Agency for...

  • Gliclazide abuse, overdose.  // Reactions Weekly;8/28/2010, Issue 1316, p23 

    The article describes the case of a 16-year-old boy who developed hypoglycaemia leading to neuroglycopenia following an overdose of gliclazide.

  • Gliclazide.  // Reactions Weekly;May2015, Vol. 1549 Issue 1, p125 

    The article presents a case study of a 48-year-old man who developed hypoglycaemia after administration of gliclazide, and mentions that the patient most likely diagnosed with type 2 diabetes.

  • Apple Trees to Sodium Glucose Co-Transporter Inhibitors: A Review of SGLT2 Inhibition. White Jr., John R. // Clinical Diabetes;Winter2010, Vol. 28 Issue 1, p5 

    The article offers information on the role of kidneys in glucose homeostasis and modulation of glucose regulatory system through pharmacological means. It also mentions about several clinical trials with diabetics. In those trials, hypoglycemia was reported in 4 percent of placebo-treated...

  • Cardiovascular Effects of Diabetes Drugs: Emerging From the Dark Ages. Nissen, Steven E. // Annals of Internal Medicine;11/6/2012, Vol. 157 Issue 9, p671 

    The author discusses the emergence of cardiovascular (CV) effects of diabetes drugs with reference to a study that was conducted by researchers C.L. Roumie, A.M. Hung and R.A. Greevy. He mentions that researchers have used the best methods available to analyze observational data including...

  • Effect of Pioglitazone -- on Energy Intake and Ghrelin in Diabetic Patients. Martin, Corby K.; Gupta, Alok K.; Smith, Steven R.; Greenway, Frank L.; Han, Hongmei; Bray, George A. // Diabetes Care;Apr2010, Vol. 33 Issue 4, p742 

    OBJECTIVE -- To measure ghrelin and energy intake in the laboratory after pioglitazone treatment. RESEARCH DESIGN AND METHODS -- This was a parallel, three-arm study with 51 obese diabetic subjects randomized to either 1) pioglitazone plus a portion-controlled diet (Pio+PC), 2) pioglitazone plus...

  • Influence of Erythropoietin on Cognitive Performance during Experimental Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Randomized Cross-Over Trial. Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger // PLoS ONE;Apr2013, Vol. 8 Issue 4, p1 

    Introduction: The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective...

  • Fasting during Ramadan: efficacy, safety, and patient acceptability of vildagliptin in diabetic patients. Aziz, Kamran M. A. // Diabetes, Metabolic Syndrome & Obesity: Targets & Therapy;2015, Vol. 8, p207 

    Diabetes management during Ramadan fasting is challenging to the physician in terms of minimizing the risk of hypoglycemia. As compared to oral hypoglycemic agents (OHAs) and sulfonylureas (SUs), which carry a higher and significant risk of hypoglycemia, newer antidiabetic agents such as...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics