Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study

Abstract

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.

Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial

“…Dipeptidyl peptidase-4 inhibitors (DPP-4i) could improve glycemic control by preventing the rapid degradation of incretin hormones and inhibiting glucagon secretion [ 7 ]. With a low risk of hypoglycemia and no weight gain, nearly 0.7% reduction in HbA1c was reported when other DPP-4 inhibitors were given either alone or in combination with metformin for the treatment of T2DM patients [ 8 – 10 ]. Fotagliptin (Salubris Pharmaceuticals, Shenzhen, China) is a selective, once-daily, novel DPP-4 inhibitor approved for glycemic management of T2DM.…”

National Council of Experts: the place of DPP-4 inhibitors in the treatment of patients with type 2 diabetes mellitus

“…Ситаглиптин активно изучался у пациентов пожилого возраста. По результатам одного из недавних мультицентровых рандомизированных исследований, добавление ситаглиптина позволяло достигать целевого значения HbA 1c <7,4% у 69,4% пациентов через 6 мес лечения, что значимо больше, чем при добавлении плацебо [32]. Важно отметить, что назначение ситаглиптина в этой группе не сопровождалось увеличением числа нежелательных явлений.…”