TY - JOUR
T1 - Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes
T2 - A randomized, double-blind, placebo-controlled trial
AU - Barzilai, Nir
AU - Guo, Hua
AU - Mahoney, Erin M.
AU - Caporossi, Suzanne
AU - Golm, Gregory T.
AU - Langdon, Ronald B.
AU - Williams-Herman, Debora
AU - Kaufman, Keith D.
AU - Amatruda, John M.
AU - Goldstein, Barry J.
AU - Steinberg, Helmut
N1 - Funding Information:
This study was sponsored by Merck & Co., Inc. USA.
PY - 2011/5
Y1 - 2011/5
N2 - 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.
AB - 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.
KW - DPP-4 inhibitor
KW - Elderly
KW - Glycemic control
KW - Incretins
KW - Sitagliptin
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U2 - 10.1185/03007995.2011.568059
DO - 10.1185/03007995.2011.568059
M3 - Article
C2 - 21428727
AN - SCOPUS:79954508355
SN - 0300-7995
VL - 27
SP - 1049
EP - 1058
JO - Current medical research and opinion
JF - Current medical research and opinion
IS - 5
ER -
