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,...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2023-01-01
|
| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-27301-9 |
| _version_ | 1797958670825291776 |
|---|---|
| author | Mototsugu Nagao Jun Sasaki Hitoshi Sugihara Kyoko Tanimura-Inagaki Taro Harada Ichiro Sakuma Shinichi Oikawa STREAM Study Investigators |
| author_facet | Mototsugu Nagao Jun Sasaki Hitoshi Sugihara Kyoko Tanimura-Inagaki Taro Harada Ichiro Sakuma Shinichi Oikawa STREAM Study Investigators |
| author_sort | Mototsugu Nagao |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T00:22:17Z |
| format | Article |
| id | doaj.art-c0603767dc4047c592aabd1280f0e133 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-11T00:22:17Z |
| publishDate | 2023-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-c0603767dc4047c592aabd1280f0e1332023-01-08T12:12:52ZengNature PortfolioScientific Reports2045-23222023-01-0113111110.1038/s41598-022-27301-9Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM studyMototsugu Nagao0Jun Sasaki1Hitoshi Sugihara2Kyoko Tanimura-Inagaki3Taro Harada4Ichiro Sakuma5Shinichi Oikawa6STREAM Study InvestigatorsDepartment of Endocrinology, Metabolism and Nephrology, Graduate School of Medicine, Nippon Medical SchoolInternational University of Health and WelfareDepartment of Endocrinology, Metabolism and Nephrology, Graduate School of Medicine, Nippon Medical SchoolDepartment of Endocrinology, Metabolism and Nephrology, Graduate School of Medicine, Nippon Medical SchoolDepartment of Endocrinology, Metabolism and Nephrology, Graduate School of Medicine, Nippon Medical SchoolCaress Sapporo Hokko Memorial ClinicDepartment of Endocrinology, Metabolism and Nephrology, Graduate School of Medicine, Nippon Medical SchoolAbstract 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.https://doi.org/10.1038/s41598-022-27301-9 |
| spellingShingle | Mototsugu Nagao Jun Sasaki Hitoshi Sugihara Kyoko Tanimura-Inagaki Taro Harada Ichiro Sakuma Shinichi Oikawa STREAM Study Investigators Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study Scientific Reports |
| title | Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study |
| title_full | Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study |
| title_fullStr | Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study |
| title_full_unstemmed | Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study |
| title_short | Efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes: the STREAM study |
| title_sort | efficacy and safety of sitagliptin treatment in older adults with moderately controlled type 2 diabetes the stream study |
| url | https://doi.org/10.1038/s41598-022-27301-9 |
| work_keys_str_mv | AT mototsugunagao efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT junsasaki efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT hitoshisugihara efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT kyokotanimurainagaki efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT taroharada efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT ichirosakuma efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT shinichioikawa efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy AT streamstudyinvestigators efficacyandsafetyofsitagliptintreatmentinolderadultswithmoderatelycontrolledtype2diabetesthestreamstudy |