title: 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.
abstract: 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.
  
  
  BACKGROUND
  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; HbA(1c) 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 HbA(1c) 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Betsi Cadwaladr University Health Board, Wales, United Kingdom.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hassanein
authors.affiliation: Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt.
authors.forename: Khalifa
authors.initials: K
authors.lastname: Abdallah
authors.affiliation: Global Medical Affairs, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Anja
authors.initials: A
authors.lastname: Schweizer
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001208:Asia; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005215:Fasting / Q000097:blood; D005260:Female; D005907:Gliclazide / Q000009:adverse effects / Q000627:therapeutic use*; D006442:Glycated Hemoglobin; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007514:Islam; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D008877:Middle East; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D009819:Office Visits; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D012068:Religion and Medicine; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D005907:Gliclazide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
keywords: Ramadan; dipeptidyl peptidase 4; fasting; hypoglycemia; incretin; type 2 diabetes mellitus