Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study

Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.


Objective: To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan.

Methods: In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan.

Results: Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated.

Limitations: Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed.

Conclusion: Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan.

Clinical trial registration: Clinicaltrials.gov: NCT01340768.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / epidemiology
  • Fasting / blood
  • Fasting / physiology*
  • Female
  • Humans
  • Hypoglycemia / chemically induced*
  • Hypoglycemia / epidemiology
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • India / epidemiology
  • Islam*
  • Malaysia / epidemiology
  • Male
  • Middle Aged
  • Pyrazines / adverse effects*
  • Pyrazines / therapeutic use
  • Sitagliptin Phosphate
  • Sulfonylurea Compounds / adverse effects*
  • Sulfonylurea Compounds / therapeutic use
  • Triazoles / adverse effects*
  • Triazoles / therapeutic use
  • Young Adult


  • Blood Glucose
  • Hypoglycemic Agents
  • Pyrazines
  • Sulfonylurea Compounds
  • Triazoles
  • Sitagliptin Phosphate

Associated data

  • ClinicalTrials.gov/NCT01340768