title: Comparison of the dipeptidyl peptidase-4 inhibitor vildagliptin and the sulphonylurea gliclazide in combination with metformin, in Muslim patients with type 2 diabetes mellitus fasting during Ramadan: results of the VECTOR study.
abstract: OBJECTIVE
  To compare the incidence of hypoglycaemic events (HEs) in a real-world setting in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
  
  
  METHODS
  We performed a ≤16-week prospective, non-interventional, two-cohort study. Data were collected 1-6 weeks before and ≤6 weeks after fasting. Patients were enrolled who had been receiving vildagliptin (50 mg twice daily) or sulphonylurea (SU) as add-on to metformin at least 4 weeks prior to fasting.
  
  
  METHODS
  The primary efficacy endpoint was incidence of HEs during the Ramadan fast. Changes in glycated haemoglobin (HbA(1c)) and body weight, as well as adherence to treatment, were also assessed.
  
  
  RESULTS
  Seventy-two patients were enrolled (vildagliptin, n = 30; SU, n = 41; no treatment, n = 1), of whom 23 (76.7%) and 36 (87.8%), respectively, completed the study. With vildagliptin, there were no HEs or severe HEs, compared with 34 HEs (15 patients, 41.7%) and one severe (grade 2) HE with SU. The mean between-group difference in the proportion who experienced at least one HE was -41.7% (95%CI -57.8%, -25.6%), p = 0.0002. Vildagliptin lowered mean HbA(1c) from 7.6% (SD 0.9%) at baseline to 7.2% (SD 0.7%) post-Ramadan, whereas SU had no effect (7.2% [SD 0.6%] vs 7.3% [SD 0.7%]; mean between-group difference -0.5% [95% CI -0.9%, -0.1%], p = 0.0262). The mean number of missed doses was markedly lower with vildagliptin (0.2 [SD 0.8] vs 7.6 [SD 14.9]; mean between-group difference -7.4 [95% CI -13.7, -1.20] doses; p = 0.0204). Body weight remained unchanged in both groups.
  
  
  CONCLUSIONS
  Vildagliptin caused no hypoglycaemia, was well adhered to and improved HbA(1c), making it a suitable treatment option for managing fasting. Study limitations are the sample size and the lack of diet and exercise data. When extrapolated to the global Muslim population with a similar clinical background, these findings could have considerable public health and clinical implications.
authors.affiliation: Betsi Cadwaladr University Health Board, Rhyl, UK.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Hassanein
authors.forename: Wasim
authors.initials: W
authors.lastname: Hanif
authors.forename: Waqar
authors.initials: W
authors.lastname: Malik
authors.forename: Ali
authors.initials: A
authors.lastname: Kamal
authors.forename: Parnia
authors.initials: P
authors.lastname: Geransar
authors.forename: Nicola
authors.initials: N
authors.lastname: Lister
authors.forename: Chris
authors.initials: C
authors.lastname: Andrews
authors.forename: Anthony
authors.initials: A
authors.lastname: Barnett
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D005215:Fasting / Q000502:physiology*; D005260:Female; D005907:Gliclazide / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007514:Islam; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D000077597:Vildagliptin
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D008687:Metformin; D005907:Gliclazide; D000077597:Vildagliptin; D000218:Adamantane