Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION)
Background This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin. Methods In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 pati...
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| Format: | Article |
| Language: | English |
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Korean Endocrine Society
2023-06-01
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| Series: | Endocrinology and Metabolism |
| Subjects: | |
| Online Access: | http://www.e-enm.org/upload/pdf/enm-2023-1688.pdf |
| _version_ | 1797786504612806656 |
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| author | Byung Wan Lee KyungWan Min Eun-Gyoung Hong Bon Jeong Ku Jun Goo Kang Suk Chon Won-Young Lee Mi Kyoung Park Jae Hyeon Kim Sang Yong Kim Keeho Song Soon Jib Yoo |
| author_facet | Byung Wan Lee KyungWan Min Eun-Gyoung Hong Bon Jeong Ku Jun Goo Kang Suk Chon Won-Young Lee Mi Kyoung Park Jae Hyeon Kim Sang Yong Kim Keeho Song Soon Jib Yoo |
| author_sort | Byung Wan Lee |
| collection | DOAJ |
| description | Background This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin. Methods In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks. Results The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was –0.66% (0.07) with a 95% confidence interval of –0.80% to –0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted. Conclusion Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin. |
| first_indexed | 2024-03-13T01:08:53Z |
| format | Article |
| id | doaj.art-87d77379d1ae4e529a0ebf5b900369c8 |
| institution | Directory Open Access Journal |
| issn | 2093-596X 2093-5978 |
| language | English |
| last_indexed | 2024-03-13T01:08:53Z |
| publishDate | 2023-06-01 |
| publisher | Korean Endocrine Society |
| record_format | Article |
| series | Endocrinology and Metabolism |
| spelling | doaj.art-87d77379d1ae4e529a0ebf5b900369c82023-07-06T05:09:22ZengKorean Endocrine SocietyEndocrinology and Metabolism2093-596X2093-59782023-06-0138332833710.3803/EnM.2023.16882402Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION)Byung Wan Lee0KyungWan Min1Eun-Gyoung Hong2Bon Jeong Ku3Jun Goo Kang4Suk Chon5Won-Young Lee6Mi Kyoung Park7Jae Hyeon Kim8Sang Yong Kim9Keeho Song10Soon Jib Yoo11 Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea Department of Endocrinology and Metabolism, Nowon Eulji Medical Center, Eulji University, Seoul, Korea Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, College of Medicine, Hallym University, Hwaseong, Korea Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea Department of Endocrinology and Metabolism, Kyung Hee University Hospital, College of Medicine, Kyung Hee University, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea Department of Internal Medicine, Chosun University Hospital, Chosun University College of Medicine, Gwangju, Korea Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea Division of Endocrinology, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Bucheon, KoreaBackground This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin. Methods In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks. Results The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was –0.66% (0.07) with a 95% confidence interval of –0.80% to –0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted. Conclusion Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.http://www.e-enm.org/upload/pdf/enm-2023-1688.pdfdipeptidyl-peptidase iv inhibitorsgemigliptinsodium-glucose transporter 2 inhibitorsdapagliflozinmetformindiabetes mellitus, type 2 |
| spellingShingle | Byung Wan Lee KyungWan Min Eun-Gyoung Hong Bon Jeong Ku Jun Goo Kang Suk Chon Won-Young Lee Mi Kyoung Park Jae Hyeon Kim Sang Yong Kim Keeho Song Soon Jib Yoo Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) Endocrinology and Metabolism dipeptidyl-peptidase iv inhibitors gemigliptin sodium-glucose transporter 2 inhibitors dapagliflozin metformin diabetes mellitus, type 2 |
| title | Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) |
| title_full | Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) |
| title_fullStr | Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) |
| title_full_unstemmed | Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) |
| title_short | Efficacy of Gemigliptin Add-on to Dapagliflozin and Metformin in Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Study (SOLUTION) |
| title_sort | efficacy of gemigliptin add on to dapagliflozin and metformin in type 2 diabetes patients a randomized double blind placebo controlled study solution |
| topic | dipeptidyl-peptidase iv inhibitors gemigliptin sodium-glucose transporter 2 inhibitors dapagliflozin metformin diabetes mellitus, type 2 |
| url | http://www.e-enm.org/upload/pdf/enm-2023-1688.pdf |
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