Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR)
Abstract Background Few prospective studies have compared the cardiovascular benefits of sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. We aimed to clarify the efficacy of dapagliflozin versus sitagliptin for modulating cardiometabolic risk factors i...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-01-01
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| Series: | Cardiovascular Diabetology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12933-019-0977-z |
| _version_ | 1818453388484935680 |
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| author | Ayako Fuchigami Fumika Shigiyama Toru Kitazawa Yosuke Okada Takamasa Ichijo Mariko Higa Toru Hiyoshi Ikuo Inoue Kaoru Iso Hidenori Yoshii Takahisa Hirose Naoki Kumashiro |
| author_facet | Ayako Fuchigami Fumika Shigiyama Toru Kitazawa Yosuke Okada Takamasa Ichijo Mariko Higa Toru Hiyoshi Ikuo Inoue Kaoru Iso Hidenori Yoshii Takahisa Hirose Naoki Kumashiro |
| author_sort | Ayako Fuchigami |
| collection | DOAJ |
| description | Abstract Background Few prospective studies have compared the cardiovascular benefits of sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. We aimed to clarify the efficacy of dapagliflozin versus sitagliptin for modulating cardiometabolic risk factors including high glycated hemoglobin (HbA1c) levels, hypoglycemia, and body weight. Methods This prospective, randomized, open-label, blinded-endpoint, parallel-group trial enrolled 340 Japanese patients with early-stage type 2 diabetes receiving metformin alone or no glucose-lowering agents, who were randomized to receive dapagliflozin or sitagliptin for 24 weeks. The primary endpoint was the proportion of patients who achieved the composite endpoint of HbA1c level maintenance < 7.0% (53 mmol/mol), avoidance of hypoglycemia (maintenance of sensor glucose ≥ 3.0 mmol/L or ≥ 54 mg/dL), and ≥ 3.0% body weight loss from baseline. Secondary endpoints included components of the primary endpoint, other metabolic indices, and glucose variability indices measured using flash glucose monitoring. Results Clinical characteristics of patients were age, 58.1 ± 12.2 years; known duration of diabetes, 5.8 ± 6.1 years; body weight, 74.7 ± 14.2 kg; body mass index, 27.9 ± 4.1 kg/m2; and HbA1c level, 7.8 ± 0.8% at baseline. The achievement ratio of primary endpoint was significantly higher in the dapagliflozin group than in the sitagliptin group (24.4% vs. 13.8%, P < 0.05). While the rates of HbA1c level maintenance < 7.0% (53 mmol/mol) and avoidance of hypoglycemia were comparable between the groups (49.4 vs. 50.0% and 88.7 vs. 92.3% for dapagliflozin vs. sitagliptin, respectively), body weight loss of ≥ 3.0% was significantly achieved in the dapagliflozin group (54.4 vs. 19.6%, P < 0.001). Moreover, dapagliflozin was superior to sitagliptin regarding several secondary endpoints that modulate cardiometabolic risk, namely reducing fasting plasma glucose, insulin, uric acid, increasing high-density lipoprotein cholesterol, and suppressing the increase in serum creatinine and the decrease in estimated glomerular filtration rate. On the other hand, sitagliptin was superior to dapagliflozin in suppressing glucose variability. Conclusions Compared to sitagliptin, dapagliflozin was significantly more effective at improving cardiometabolic risk factors, suggesting that SGLT2 inhibitors might be more suitable than DPP-4 inhibitors for preventing cardiovascular events in patients with early-stage but inadequately controlled type 2 diabetes. Trial registration Trial number, UMIN000028014; registered on June 30, 2017 |
| first_indexed | 2024-12-14T21:38:12Z |
| format | Article |
| id | doaj.art-07449c614cb643b6a1765e863a8f077f |
| institution | Directory Open Access Journal |
| issn | 1475-2840 |
| language | English |
| last_indexed | 2024-12-14T21:38:12Z |
| publishDate | 2020-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Cardiovascular Diabetology |
| spelling | doaj.art-07449c614cb643b6a1765e863a8f077f2022-12-21T22:46:32ZengBMCCardiovascular Diabetology1475-28402020-01-0119111110.1186/s12933-019-0977-zEfficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR)Ayako Fuchigami0Fumika Shigiyama1Toru Kitazawa2Yosuke Okada3Takamasa Ichijo4Mariko Higa5Toru Hiyoshi6Ikuo Inoue7Kaoru Iso8Hidenori Yoshii9Takahisa Hirose10Naoki Kumashiro11Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of MedicineDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of MedicineDivision of Diabetes, Endocrinology and Metabolism, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental HealthDepartment of Diabetes and Endocrinology, Saiseikai Yokohamashi Tobu HospitalDepartment of Diabetes and Endocrinology, Saiseikai Yokohamashi Tobu HospitalDivision of Diabetes and Endocrinology, Japanese Red Cross Medical CenterDepartment of Endocrinology and Diabetes, School of Medicine, Saitama Medical UniversityDepartment of Internal Medicine, Japan Community Health Care Organization Tokyo Kamata Medical CenterDepartment of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical CenterDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of MedicineDivision of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of MedicineAbstract Background Few prospective studies have compared the cardiovascular benefits of sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase 4 (DPP-4) inhibitors. We aimed to clarify the efficacy of dapagliflozin versus sitagliptin for modulating cardiometabolic risk factors including high glycated hemoglobin (HbA1c) levels, hypoglycemia, and body weight. Methods This prospective, randomized, open-label, blinded-endpoint, parallel-group trial enrolled 340 Japanese patients with early-stage type 2 diabetes receiving metformin alone or no glucose-lowering agents, who were randomized to receive dapagliflozin or sitagliptin for 24 weeks. The primary endpoint was the proportion of patients who achieved the composite endpoint of HbA1c level maintenance < 7.0% (53 mmol/mol), avoidance of hypoglycemia (maintenance of sensor glucose ≥ 3.0 mmol/L or ≥ 54 mg/dL), and ≥ 3.0% body weight loss from baseline. Secondary endpoints included components of the primary endpoint, other metabolic indices, and glucose variability indices measured using flash glucose monitoring. Results Clinical characteristics of patients were age, 58.1 ± 12.2 years; known duration of diabetes, 5.8 ± 6.1 years; body weight, 74.7 ± 14.2 kg; body mass index, 27.9 ± 4.1 kg/m2; and HbA1c level, 7.8 ± 0.8% at baseline. The achievement ratio of primary endpoint was significantly higher in the dapagliflozin group than in the sitagliptin group (24.4% vs. 13.8%, P < 0.05). While the rates of HbA1c level maintenance < 7.0% (53 mmol/mol) and avoidance of hypoglycemia were comparable between the groups (49.4 vs. 50.0% and 88.7 vs. 92.3% for dapagliflozin vs. sitagliptin, respectively), body weight loss of ≥ 3.0% was significantly achieved in the dapagliflozin group (54.4 vs. 19.6%, P < 0.001). Moreover, dapagliflozin was superior to sitagliptin regarding several secondary endpoints that modulate cardiometabolic risk, namely reducing fasting plasma glucose, insulin, uric acid, increasing high-density lipoprotein cholesterol, and suppressing the increase in serum creatinine and the decrease in estimated glomerular filtration rate. On the other hand, sitagliptin was superior to dapagliflozin in suppressing glucose variability. Conclusions Compared to sitagliptin, dapagliflozin was significantly more effective at improving cardiometabolic risk factors, suggesting that SGLT2 inhibitors might be more suitable than DPP-4 inhibitors for preventing cardiovascular events in patients with early-stage but inadequately controlled type 2 diabetes. Trial registration Trial number, UMIN000028014; registered on June 30, 2017https://doi.org/10.1186/s12933-019-0977-zType 2 diabetesCardiometabolic risk factorsDapagliflozinSitagliptinGlycemic controlWeight loss |
| spellingShingle | Ayako Fuchigami Fumika Shigiyama Toru Kitazawa Yosuke Okada Takamasa Ichijo Mariko Higa Toru Hiyoshi Ikuo Inoue Kaoru Iso Hidenori Yoshii Takahisa Hirose Naoki Kumashiro Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) Cardiovascular Diabetology Type 2 diabetes Cardiometabolic risk factors Dapagliflozin Sitagliptin Glycemic control Weight loss |
| title | Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) |
| title_full | Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) |
| title_fullStr | Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) |
| title_full_unstemmed | Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) |
| title_short | Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR) |
| title_sort | efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in japanese patients with type 2 diabetes a prospective randomized study diversity cvr |
| topic | Type 2 diabetes Cardiometabolic risk factors Dapagliflozin Sitagliptin Glycemic control Weight loss |
| url | https://doi.org/10.1186/s12933-019-0977-z |
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