title: The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial.
abstract: OBJECTIVE
  To compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan.
  
  
  METHODS
  Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end-point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan.
  
  
  RESULTS
  Of the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel-Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan.
  
  
  CONCLUSIONS
  In Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin-based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea-based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.
authors.affiliation: Al Hada Military Hospital, Taif, Saudi Arabia.
authors.forename: S
authors.initials: S
authors.lastname: Al Sifri
authors.forename: A
authors.initials: A
authors.lastname: Basiounny
authors.forename: A
authors.initials: A
authors.lastname: Echtay
authors.forename: M
authors.initials: M
authors.lastname: Al Omari
authors.forename: I
authors.initials: I
authors.lastname: Harman-Boehm
authors.forename: G
authors.initials: G
authors.lastname: Kaddaha
authors.forename: K
authors.initials: K
authors.lastname: Al Tayeb
authors.forename: A S
authors.initials: AS
authors.lastname: Mahfouz
authors.forename: A
authors.initials: A
authors.lastname: Al Elq
authors.forename: L
authors.initials: L
authors.lastname: Radican
authors.forename: C
authors.initials: C
authors.lastname: Ozesen
authors.forename: H L
authors.initials: HL
authors.lastname: Katzeff
authors.forename: B J
authors.initials: BJ
authors.lastname: Musser
authors.forename: S
authors.initials: S
authors.lastname: Suryawanshi
authors.forename: C J
authors.initials: CJ
authors.lastname: Girman
authors.forename: M J
authors.initials: MJ
authors.lastname: Davies
authors.forename: S S
authors.initials: SS
authors.lastname: Engel
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D057915:Drug Substitution; D005215:Fasting; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000209:etiology*; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015994:Incidence; D007514:Islam; D008297:Male; D008875:Middle Aged; D008877:Middle East / Q000453:epidemiology; D011719:Pyrazines / Q000627:therapeutic use*; D012111:Residence Characteristics; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D014230:Triazoles / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D011719:Pyrazines; D013453:Sulfonylurea Compounds; D014230:Triazoles; D000068900:Sitagliptin Phosphate