title: Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.
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 ≥ 65 years.
  
  
  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 (HbA(1c)), 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.
  
  
  BACKGROUND
  NCT00305604.
  
  
  RESULTS
  Among randomized patients (N = 206), mean age was 72 years and mean baseline HbA(1c) was 7.8%. At week 24, HbA(1c) 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 HbA(1c) <8.0% (n = 132), ≥ 8.0% to <9.0% (n = 42), and ≥ 9.0% (n = 18), the placebo-adjusted reductions in HbA(1c) 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 (HbA(1c) ≥ 9.0%) and the exclusion of patients with severe renal insufficiency.
  
  
  CONCLUSIONS
  In this study, sitagliptin treatment significantly and rapidly improved glycemic measures and was well tolerated in patients aged ≥ 65 years with type 2 diabetes.
authors.affiliation: Merck Research Laboratories, Rahway, NJ 07065-0900, USA.
authors.forename: Nir
authors.initials: N
authors.lastname: Barzilai
authors.forename: Hua
authors.initials: H
authors.lastname: Guo
authors.forename: Erin M
authors.initials: EM
authors.lastname: Mahoney
authors.forename: Suzanne
authors.initials: S
authors.lastname: Caporossi
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Golm
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Langdon
authors.forename: Debora
authors.initials: D
authors.lastname: Williams-Herman
authors.forename: Keith D
authors.initials: KD
authors.lastname: Kaufman
authors.forename: John M
authors.initials: JM
authors.lastname: Amatruda
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Goldstein
authors.forename: Helmut
authors.initials: H
authors.lastname: Steinberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D008297:Male; D011719:Pyrazines / Q000008:administration & dosage* / Q000009:adverse effects; D000068900:Sitagliptin Phosphate; D013997:Time Factors; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D011719:Pyrazines; D000068900:Sitagliptin Phosphate; D014230:Triazoles; C517652:hemoglobin A1c protein, human