Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes : the STREAM study
(2023) In Scientific Reports 13. p.1-11- 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... (More)
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.
(Less)
- author
- Nagao, Mototsugu LU ; Sasaki, Jun ; Sugihara, Hitoshi ; Tanimura-Inagaki, Kyoko ; Harada, Taro ; Sakuma, Ichiro and Oikawa, Shinichi
- author collaboration
- publishing date
- 2023-01-04
- type
- Contribution to journal
- publication status
- published
- keywords
- Humans, Aged, Sitagliptin Phosphate/adverse effects, Diabetes Mellitus, Type 2/drug therapy, Hypoglycemic Agents/adverse effects, Glycated Hemoglobin, Dipeptidyl-Peptidase IV Inhibitors/adverse effects, Drug Therapy, Combination, Treatment Outcome, Double-Blind Method, Metformin/therapeutic use, Blood Glucose
- in
- Scientific Reports
- volume
- 13
- article number
- 134
- pages
- 1 - 11
- publisher
- Nature Publishing Group
- external identifiers
-
- scopus:85145537178
- pmid:36599895
- ISSN
- 2045-2322
- DOI
- 10.1038/s41598-022-27301-9
- language
- English
- LU publication?
- no
- additional info
- © 2023. The Author(s).
- id
- 1c6bfdac-2a4a-4625-b785-5c78482d97ed
- date added to LUP
- 2023-01-12 02:10:14
- date last changed
- 2024-06-13 12:31:44
@article{1c6bfdac-2a4a-4625-b785-5c78482d97ed,
abstract = {{<p>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.</p>}},
author = {{Nagao, Mototsugu and Sasaki, Jun and Sugihara, Hitoshi and Tanimura-Inagaki, Kyoko and Harada, Taro and Sakuma, Ichiro and Oikawa, Shinichi}},
issn = {{2045-2322}},
keywords = {{Humans; Aged; Sitagliptin Phosphate/adverse effects; Diabetes Mellitus, Type 2/drug therapy; Hypoglycemic Agents/adverse effects; Glycated Hemoglobin; Dipeptidyl-Peptidase IV Inhibitors/adverse effects; Drug Therapy, Combination; Treatment Outcome; Double-Blind Method; Metformin/therapeutic use; Blood Glucose}},
language = {{eng}},
month = {{01}},
pages = {{1--11}},
publisher = {{Nature Publishing Group}},
series = {{Scientific Reports}},
title = {{Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes : the STREAM study}},
url = {{http://dx.doi.org/10.1038/s41598-022-27301-9}},
doi = {{10.1038/s41598-022-27301-9}},
volume = {{13}},
year = {{2023}},
}