Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial

Nir Barzilai, Hua Guo, Erin M. Mahoney, Suzanne Caporossi, Gregory T. Golm, Ronald B. Langdon, Debora Williams-Herman, Keith D. Kaufman, John M. Amatruda, Barry J. Goldstein, Helmut Steinberg

Research output: Contribution to journalArticlepeer-review

107 Scopus citations

Abstract

Objective: Type 2 diabetes in the elderly is an important and insufficiently studied public health problem. This study evaluated sitagliptin monotherapy in patients with type 2 diabetes aged â‰1 65 years. Research design and methods: This was a randomized, double-blind, placebo-controlled, parallel-group study conducted at 52 sites in the United States. Patients were treated with once-daily sitagliptin (100 or 50 mg, depending on renal function) or placebo for 24 weeks. Key endpoints included change from baseline in glycated hemoglobin (HbA1c), 2-hour post-meal glucose (2-h PMG) and fasting plasma glucose (FPG) at week 24, and average blood glucose on treatment days 3 and 7. Clinical trial registration: NCT00305604. Results: Among randomized patients (N=206), mean age was 72 years and mean baseline HbA1c was 7.8%. At week 24, HbA1c decreased by 0.7%, 2-h PMG by 61 mg/dL, and FPG by 27 mg/dL in sitagliptin-treated patients compared with placebo (all p<0.001). On day 3 of treatment, mean average blood glucose was decreased from baseline by 20.4 mg/dL in sitagliptin-treated patients compared with placebo (p<0.001). In subgroups defined by baseline HbA1c <8.0% (n=132), ≥8.0% to <9.0% (n=42), and ≥9.0% (n=18), the placebo-adjusted reductions in HbA1c with sitagliptin treatment were 0.5%, 0.9%, and 1.6%, respectively. Patients in the sitagliptin and placebo groups had similar rates of adverse events overall (46.1% and 52.9%, respectively); serious adverse events were reported in 6.9% and 13.5%, respectively. No adverse events of hypoglycemia were reported. Potential study limitations include a relatively small number of patients with more severe hyperglycemia (HbA1c ≥.0%) and the exclusion of patients with severe renal insufficiency. Conclusion: In this study, sitagliptin treatment significantly and rapidly improved glycemic measures and was well tolerated in patients aged ≥65 years with type 2 diabetes.

Original languageEnglish (US)
Pages (from-to)1049-1058
Number of pages10
JournalCurrent medical research and opinion
Volume27
Issue number5
DOIs
StatePublished - May 2011
Externally publishedYes

Keywords

  • DPP-4 inhibitor
  • Elderly
  • Glycemic control
  • Incretins
  • Sitagliptin

ASJC Scopus subject areas

  • Medicine(all)

Fingerprint Dive into the research topics of 'Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial'. Together they form a unique fingerprint.

Cite this