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Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study
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Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study
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Journal Article
Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study
2023
Overview
Sitagliptin has been suggested as a treatment option for older adults with type 2 diabetes (T2D). However, no randomized controlled trial has been performed to evaluate the efficacy and safety of sitagliptin treatment in older Japanese patients with T2D. The STREAM study was a multicenter, open-label, randomized controlled trial. T2D outpatients aged 65–80 years with moderately controlled glycemic levels (HbA1c 7.4–10.4%) under lifestyle interventions without or with oral anti-diabetic drugs excluding DPP4 inhibitors or GLP-1 receptor agonists were recruited (n = 176). The participants were randomized into sitagliptin group (n = 88) who received sitagliptin as an initial or an additive anti-diabetic drug and control group (n = 88) who did not. The treatment goal was HbA1c level < 7.4%. Efficacy and safety during 12-month treatment period were investigated. The mean (± SD) ages were 70.6 ± 3.9 and 71.9 ± 4.4 years old in sitagliptin and control groups, respectively. According to a mixed-effects model analysis, average changes from baseline over the treatment period in fasting plasma glucose (FPG), HbA1c, and glycated albumin (GA) were − 27.2 mg/dL, − 0.61%, and − 2.39%, respectively, in sitagliptin group, and 0.50 mg/dL, − 0.29%, and − 0.93%, respectively, in control group. The reductions in FPG, HbA1c, and GA were significantly greater in sitagliptin group (P < 0.0001, P < 0.01, and P < 0.0001, respectively). There were no differences in the incidence of adverse effects, except for cystatin C elevation and platelet count reduction in sitagliptin group. Sitagliptin treatment effectively improved the glycemic profile without any serious adverse effects in older T2D patients.
Trial registration number:
UMIN000010376.
Publisher
Springer Science and Business Media LLC,Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ Aged
/ Diabetes
/ Diabetes mellitus (non-insulin dependent)
/ Diabetes Mellitus, Type 2 - drug therapy
/ Dipeptidyl-Peptidase IV Inhibitors
/ Dipeptidyl-Peptidase IV Inhibitors - adverse effects
/ Glycated Hemoglobin - chemistry
/ Humanities and Social Sciences
/ Humans
/ Hypoglycemic Agents - adverse effects
/ Hypoglycemic Agents - therapeutic use
/ Medicine
/ Q
/ R
/ Safety
/ Science
/ Sitagliptin Phosphate - adverse effects
