Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
BackgroundWe evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin.MethodsA total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, si...
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| Format: | Article |
| Language: | English |
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Korean Diabetes Association
2019-06-01
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| Series: | Diabetes & Metabolism Journal |
| Subjects: | |
| Online Access: | http://e-dmj.org/upload/pdf/dmj-43-287.pdf |
| _version_ | 1819204411214266368 |
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| author | Hae Kyung Yang Seung-Hwan Lee Juyoung Shin Yoon-Hee Choi Yu-Bae Ahn Byung-Wan Lee Eun Jung Rhee Kyung Wan Min Kun-Ho Yoon |
| author_facet | Hae Kyung Yang Seung-Hwan Lee Juyoung Shin Yoon-Hee Choi Yu-Bae Ahn Byung-Wan Lee Eun Jung Rhee Kyung Wan Min Kun-Ho Yoon |
| author_sort | Hae Kyung Yang |
| collection | DOAJ |
| description | BackgroundWe evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin.MethodsA total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24.ResultsThe add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups.ConclusionIn conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake. |
| first_indexed | 2024-12-23T04:35:23Z |
| format | Article |
| id | doaj.art-abad90de594048a5b452a93b8bbc49a8 |
| institution | Directory Open Access Journal |
| issn | 2233-6079 2233-6087 |
| language | English |
| last_indexed | 2024-12-23T04:35:23Z |
| publishDate | 2019-06-01 |
| publisher | Korean Diabetes Association |
| record_format | Article |
| series | Diabetes & Metabolism Journal |
| spelling | doaj.art-abad90de594048a5b452a93b8bbc49a82022-12-21T17:59:55ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872019-06-0143328730110.4093/dmj.2018.0054626Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled StudyHae Kyung Yang0Seung-Hwan Lee1Juyoung Shin2Yoon-Hee Choi3Yu-Bae Ahn4Byung-Wan Lee5Eun Jung Rhee6Kyung Wan Min7Kun-Ho Yoon8Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaDivision of Endocrinology and Metabolism, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, .KoreaDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, .KoreaDivision of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, .KoreaDepartment of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, .KoreaBackgroundWe evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin.MethodsA total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24.ResultsThe add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (−0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups.ConclusionIn conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.http://e-dmj.org/upload/pdf/dmj-43-287.pdfacarbosediabetes mellitus, type 2drug therapy, combinationmetforminsitagliptin phosphate |
| spellingShingle | Hae Kyung Yang Seung-Hwan Lee Juyoung Shin Yoon-Hee Choi Yu-Bae Ahn Byung-Wan Lee Eun Jung Rhee Kyung Wan Min Kun-Ho Yoon Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Diabetes & Metabolism Journal acarbose diabetes mellitus, type 2 drug therapy, combination metformin sitagliptin phosphate |
| title | Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study |
| title_full | Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study |
| title_fullStr | Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study |
| title_full_unstemmed | Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study |
| title_short | Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study |
| title_sort | acarbose add on therapy in patients with type 2 diabetes mellitus with metformin and sitagliptin failure a multicenter randomized double blind placebo controlled study |
| topic | acarbose diabetes mellitus, type 2 drug therapy, combination metformin sitagliptin phosphate |
| url | http://e-dmj.org/upload/pdf/dmj-43-287.pdf |
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