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

Abstract

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.

• Authors: S R Aravind, Shaiful Bahari Ismail, R Balamurugan, Jugal Bihari Gupta, Tarun Wadhwa, Sze Min Loh, Shailaja Suryawanshi, Michael J Davies, Cynthia J Girman, Harvey L Katzeff, Larry Radican, Samuel S Engel, Troels Wolthers
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 28 Issue 8 Pg. 1289-96 (Aug 2012) ISSN: 1473-4877 [Electronic] England
• PMID: 22738801 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

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