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


CONCLUSIONS
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.


CONCLUSIONS
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.


BACKGROUND
Clinicaltrials.gov: NCT01340768.
Diacon Hospital, Bangalore, India. draravind@hotmail.com
S R
SR
Aravind
Shaiful Bahari
SB
Ismail
R
R
Balamurugan
Jugal Bihari
JB
Gupta
Tarun
T
Wadhwa
Sze Min
SM
Loh
Shailaja
S
Suryawanshi
Michael J
MJ
Davies
Cynthia J
CJ
Girman
Harvey L
HL
Katzeff
Larry
L
Radican
Samuel S
SS
Engel
Troels
T
Wolthers
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D005215:Fasting / Q000097:blood / Q000502:physiology*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced* / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007194:India / Q000453:epidemiology; D007514:Islam; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects* / Q000627:therapeutic use; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D014230:Triazoles / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D011719:Pyrazines; D013453:Sulfonylurea Compounds; D014230:Triazoles; D000068900:Sitagliptin Phosphate