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Original Articles
- Pharmacotherapy
- Efficacy and Safety of High-Dose Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
- Jun Hwa Hong, Kyung Ah Han, You-Cheol Hwang, Eun-Gyoung Hong, Hae Jin Kim, Chang Beom Lee, Ho Chan Cho, Jong Chul Won, Hun-Sung Kim, Eui-Hyun Kim, Gwanpyo Koh, Kwang Hyun Ahn, Kyong Soo Park
- Received November 14, 2024 Accepted May 29, 2025 Published online October 28, 2025
- DOI: https://doi.org/10.4093/dmj.2024.0696 [Epub ahead of print]
- 4,326 View
- 93 Download
-
Abstract
PDF
Supplementary Material
PubReader 
ePub - Background
This study investigated the efficacy and safety of pioglitazone 30 mg/day add-on to inadequately controlled type 2 diabetes mellitus (T2DM) patients with treatment of dapagliflozin and metformin.
Methods
In this multicenter (34 sites), double-blind, randomized, phase 3 study, patients with T2DM with an inadequately controlled glycosylated hemoglobin (HbA1c) over 7.0% to treatment with dapagliflozin (10 mg/day) and metformin (≥1,000 mg/day) were randomized to receive additional pioglitazone 30 mg/day (n=124) or placebo (n=122) for 24 weeks. The primary outcome was the mean change of HbA1c from baseline to 24 weeks treatment. The efficacy and safety were evaluated with open label extension period, switching placebo to pioglitazone 30 mg/day at 48 weeks (ClinicalTrials.gov identifier: NCT05296044).
Results
The HbA1c after 24 weeks treatment reduced from 7.8%±0.8% to 7.0%±0.6% (P<0.0001). The proportions of patients who achieved HbA1c less than 7.0% at 24 weeks were significantly higher in pioglitazone add-on group (51.61% in pioglitazone vs. 22.95% in placebo, P<0.0001), or less than 6.5% at 24 weeks (21.77% in pioglitazone vs. 2.46% in placebo, P<0.0001). Body weight gain was 2.0 kg at 24 weeks with pioglitazone 30 mg/day and –0.6 kg at 24 weeks with placebo.
Conclusion
Addition of pioglitazone 30 mg/day to T2DM patients who did not reach the target HbA1c (≤7%) with treatment of dapagliflozin 10 mg/day and metformin over 1,000 mg/day showed effective glucose lowering efficacy without significant hypoglycemia and good tolerability with low prevalence of edema in spite of modest weight gain.
- Drug/Regimen
- Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
- Ji Hye Heo, Kyung Ah Han, Jun Hwa Hong, Hyun-Ae Seo, Eun-Gyoung Hong, Jae Myung Yu, Hye Seung Jung, Bong-Soo Cha
- Diabetes Metab J. 2024;48(5):937-948. Published online February 2, 2024
- DOI: https://doi.org/10.4093/dmj.2023.0314
- 19,815 View
- 736 Download
- 6 Web of Science
- 10 Crossref
-
Abstract
PDFSupplementary MaterialPubReader ePub
- Background
This study assessed the efficacy and safety of triple therapy with pioglitazone 15 mg add-on versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and dapagliflozin.
Methods
In this multicenter, double-blind, randomized, phase 3 study, patients with T2DM with an inadequate response to treatment with metformin (≥1,000 mg/day) plus dapagliflozin (10 mg/day) were randomized to receive additional pioglitazone 15 mg/day (n=125) or placebo (n=125) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) levels from baseline to week 24 (ClinicalTrials.gov identifier: NCT05101135).
Results
At week 24, the adjusted mean change from baseline in HbA1c level compared with placebo was significantly greater with pioglitazone treatment (–0.47%; 95% confidence interval, –0.61 to –0.33; P<0.0001). A greater proportion of patients achieved HbA1c <7% or <6.5% at week 24 with pioglitazone compared to placebo as add-on to 10 mg dapagliflozin and metformin (56.8% vs. 28% for HbA1c <7%, and 23.2% vs. 9.6% for HbA1c <6.5%; P<0.0001 for all). The addition of pioglitazone also significantly improved triglyceride, highdensity lipoprotein cholesterol levels, and homeostatic model assessment of insulin resistance levels, while placebo did not. The incidence of treatment-emergent adverse events was similar between the groups, and the incidence of fluid retention-related side effects by pioglitazone was low (1.5%).
Conclusion
Triple therapy with the addition of 15 mg/day of pioglitazone to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with T2DM inadequately controlled with dapagliflozin plus metformin. -
Citations
Citations to this article as recorded by
- Lobeglitazone improves glycaemic control as add‐on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double‐blind, randomised, placebo‐controlled trial
Da Hea Seo, Kyung Wan Min, Ho Sang Sohn, Sang Yong Kim, In‐Kyung Jeong, Cheol‐Young Park, Kun‐Ho Yoon, So Hun Kim, Bong‐Soo Cha
Diabetes, Obesity and Metabolism.2026; 28(1): 728. CrossRef - Efficacy and Safety of Pioglitazone Add‐On in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials
Ubaid Khan, Zuhair Majeed, Muhammad Haris Khan, Ahmed Bostamy Elsnhory, Ahmed Mazen Amin, Anum Nawaz, Ahmed Raza, Hafiz Muhammad Waqas Siddque, Mustafa Turkmani, Mohamed Abuelazm
Endocrinology, Diabetes & Metabolism.2025;[Epub] CrossRef - Pioglitazone as Add-On to Metformin and Dapagliflozin Yields Significant Enhancements in Glycemic Control in Poorly Controlled Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials
Sara Sabbagh, Ahmed Hegazy, Ahmed Adel, Abdullah Ali, Mohamed Alquddosy, Sara Khalid, Abdallah M Ibrahim, Ahmed Mohamed, Abdelrahman Mostafa, Ahmed Hassan, Ola Mohamed, Rawan Mesbah, Osama Osman, Mohamed Hamouda Elkasaby
Cureus.2025;[Epub] CrossRef - Triple oral therapy with metformin, DPP‐4 inhibitor, and SGLT2 inhibitor for adults with type 2 diabetes: Consensus recommendations of a Chinese expert panel (version 2025)
Miao Yu, Tong Wang, Chun Xu, Yan Bi, Ling Gao, Guang Wang, Guangda Xiang, Yaoming Xue, Tao Yang, Deying Kang, Zhiguang Zhou, Lixin Guo, Xinhua Xiao
Diabetes, Obesity and Metabolism.2025; 27(S9): 3. CrossRef - Thiazolidinediones for people with chronic kidney disease and diabetes
Patrizia Natale, Suetonia C Green, David J Tunnicliffe, Giovanni Pellegrino, Tadashi Toyama, Pantelis Sarafidis, Giovanni FM Strippoli
Cochrane Database of Systematic Reviews.2025;[Epub] CrossRef - Targeting adipose remodeling: Synergistic mechanisms of drugs and adipose-derived stem cells in obese type 2 diabetes mellitus
Cheng Luo, Xian-Mei Yu, Liang-Yan Hua, Mei-Qi Zeng, Hui Xu, Cheng-Zheng Duan, Shi-Yu Xu, Da Sun, Li-Ya Ye, Dong-Juan He
World Journal of Stem Cells.2025;[Epub] CrossRef - Sodium‐glucose cotransporter 2 inhibitor ameliorates thiazolidinedione‐induced fluid retention through vascular leakage reduction in white adipose tissue
Ji Yoon Kim, Hye‐Min Jang, Hye‐Jin Lee, Ah Hyeon Lee, Dong‐Hoon Kim, Sin Gon Kim, Nam Hoon Kim
Diabetes, Obesity and Metabolism.2025;[Epub] CrossRef - Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study
Kyuho Kim, Seung-Hyun Ko, Jae-Seung Yun, Kwan-Woo Lee, Eun Sook Kim, In-Kyung Jeong, Jae Hyeon Kim, Sang Yong Kim, Kyu Chang Won, Mikyung Kim, Bong-Soo Cha, Sungrae Kim, Sung Hee Choi, Eun-Jung Rhee, Sin Gon Kim, Bo Hyun Kim, Kang Seo Park, Young-Cheol Ju
Scientific Reports.2025;[Epub] CrossRef - Identification and validation of biomarkers related to mitochondria-associated endoplasmic reticulum membranes in type 2 diabetes mellitus using peripheral blood transcriptomics
Sufen Li, Yanqiong Yan, Qianjun Luo, Ruifei Tian, Jiahe Yan
European Journal of Medical Research.2025;[Epub] CrossRef - Ideal Combination of Oral Hypoglycemic Agents for Patients with Type 2 Diabetes Mellitus
Hye Soon Kim
Diabetes & Metabolism Journal.2024; 48(5): 882. CrossRef
- Lobeglitazone improves glycaemic control as add‐on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double‐blind, randomised, placebo‐controlled trial
- Drug Regimen
- Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension
- Jun Sung Moon, Il Rae Park, Hae Jin Kim, Choon Hee Chung, Kyu Chang Won, Kyung Ah Han, Cheol-Young Park, Jong Chul Won, Dong Jun Kim, Gwan Pyo Koh, Eun Sook Kim, Jae Myung Yu, Eun-Gyoung Hong, Chang Beom Lee, Kun-Ho Yoon
- Diabetes Metab J. 2023;47(6):808-817. Published online September 26, 2023
- DOI: https://doi.org/10.4093/dmj.2022.0387
- 9,714 View
- 519 Download
- 6 Web of Science
- 7 Crossref
-
Abstract
PDFSupplementary MaterialPubReader ePub
- Background
This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.
Methods
In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).
Results
Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, –0.65% and –0.55%; 95% confidence interval [CI], –0.79 to –0.51 and –0.71 to –0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group.
Conclusion
Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated. -
Citations
Citations to this article as recorded by- Clinical-economic assessment of the potential contribution of evogliptin to achieving the targets of the Federal project «Fight against diabetes mellitus» and reduction of population mortality
N. N. Avxentyev, A. S. Makarov, I. A. Karpova, V. V. Yavlyanskaya
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice.2025; (4): 55. CrossRef - Design, synthesis, and biological evaluation of quinazolinone-dihydropyrimidinone as a potential anti-diabetic agent via GLUT4 translocation stimulation
Arvind Kumar Jaiswal, Ajay Kishor Kushawaha, Pawan kumar, Alisha Ansari, Nikita Chhikara, Hemlata bhatt, Sarita Katiyar, Ishbal Ahmad, Abhijit Deb Choudhury, Rabi Sankar Bhatta, Akhilesh K. Tamrakar, Koneni V. Sashidhara
European Journal of Medicinal Chemistry.2025; 288: 117366. CrossRef - Efficacy and safety of combination therapy using SGLT2 and DPP4 inhibitors to treat type 2 diabetes: An updated systematic review and meta‐analysis with focus on an Asian subpopulation
Myung Jin Kim, Yun Kyung Cho, Sehee Kim, Jung Yoon Moon, Chang Hee Jung, Woo Je Lee
Diabetes, Obesity and Metabolism.2025; 27(9): 5019. CrossRef - Comparative efficacy and safety of Evogliptin in type 2 diabetes patients above and below 65 years
Jimi Kim, Young‐Seol Kim, You‐Cheol Hwang, Jung‐Eun Yim
Diabetes, Obesity and Metabolism.2025; 27(10): 6084. CrossRef - Efficacy and safety of chiglitazar add‐on to metformin in type 2 diabetes mellitus (RECAM study)
Leili Gao, Linong Ji, Xin Yan, Zhifeng Cheng, Xin Zhang, Wenli Sun, Jianhua Ma, Weihong Song, Yu Liu, Xiaohong Lin, Wuyan Pang, Haixiang Cao, Bo Chen, Zhibin Li, Xianping Lu
Diabetes, Obesity and Metabolism.2025; 27(11): 6243. CrossRef - Triple oral therapy with metformin, DPP‐4 inhibitor, and SGLT2 inhibitor for adults with type 2 diabetes: Consensus recommendations of a Chinese expert panel (version 2025)
Miao Yu, Tong Wang, Chun Xu, Yan Bi, Ling Gao, Guang Wang, Guangda Xiang, Yaoming Xue, Tao Yang, Deying Kang, Zhiguang Zhou, Lixin Guo, Xinhua Xiao
Diabetes, Obesity and Metabolism.2025; 27(S9): 3. CrossRef - Efficacy and safety of dapagliflozin add‐on to evogliptin plus metformin therapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled study
In‐Kyung Jeong, Kyung Mook Choi, Kyung Ah Han, Kyoung‐Ah Kim, In Joo Kim, Seung Jin Han, Won Young Lee, Soon Jib Yoo
Diabetes, Obesity and Metabolism.2024; 26(11): 5065. CrossRef
- Clinical-economic assessment of the potential contribution of evogliptin to achieving the targets of the Federal project «Fight against diabetes mellitus» and reduction of population mortality
- Drug Regimen
- Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial
- Kyung Ah Han, Yong Hyun Kim, Doo Man Kim, Byung Wan Lee, Suk Chon, Tae Seo Sohn, In Kyung Jeong, Eun-Gyoung Hong, Jang Won Son, Jae Jin Nah, Hwa Rang Song, Seong In Cho, Seung-Ah Cho, Kun Ho Yoon
- Diabetes Metab J. 2023;47(6):796-807. Published online February 9, 2023
- DOI: https://doi.org/10.4093/dmj.2022.0315
- 50,076 View
- 839 Download
- 14 Web of Science
- 16 Crossref
-
Abstract
PDFSupplementary MaterialPubReader ePub
- Background
Enavogliflozin is a novel sodium-glucose cotransporter-2 inhibitor currently under clinical development. This study evaluated the efficacy and safety of enavogliflozin as an add-on to metformin in Korean patients with type 2 diabetes mellitus (T2DM) against dapagliflozin.
Methods
In this multicenter, double-blind, randomized, phase 3 study, 200 patients were randomized to receive enavogliflozin 0.3 mg/day (n=101) or dapagliflozin 10 mg/day (n=99) in addition to ongoing metformin therapy for 24 weeks. The primary objective of the study was to prove the non-inferiority of enavogliflozin to dapagliflozin in glycosylated hemoglobin (HbA1c) change at week 24 (non-inferiority margin of 0.35%) (Clinical trial registration number: NCT04634500).
Results
Adjusted mean change of HbA1c at week 24 was –0.80% with enavogliflozin and –0.75% with dapagliflozin (difference, –0.04%; 95% confidence interval, –0.21% to 0.12%). Percentages of patients achieving HbA1c <7.0% were 61% and 62%, respectively. Adjusted mean change of fasting plasma glucose at week 24 was –32.53 and –29.14 mg/dL. An increase in urine glucose-creatinine ratio (60.48 vs. 44.94, P<0.0001) and decrease in homeostasis model assessment of insulin resistance (–1.85 vs. –1.31, P=0.0041) were significantly greater with enavogliflozin than dapagliflozin at week 24. Beneficial effects of enavogliflozin on body weight (–3.77 kg vs. –3.58 kg) and blood pressure (systolic/diastolic, –5.93/–5.41 mm Hg vs. –6.57/–4.26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated.
Conclusion
Enavogliflozin added to metformin significantly improved glycemic control in patients with T2DM and was non-inferior to dapagliflozin 10 mg, suggesting enavogliflozin as a viable treatment option for patients with inadequate glycemic control on metformin alone. -
Citations
Citations to this article as recorded by- Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon Kim, Soo Lim, In-Kyung Jeong, Eun-Jung Rhee, Jun Sung Moon, Ohk-Hyun Ryu, Hyuk-Sang Kwon, Jong Chul Won, Sang Soo Kim, Sang Yong Kim, Bon Jeong Ku, Heung Yong Jin, Sin Gon Kim, Bong-Soo Cha
Diabetes & Metabolism Journal.2025; 49(2): 225. CrossRef - Efficacy and safety of 11 sodium-glucose cotransporter-2 inhibitors at different dosages in type 2 diabetes mellitus patients inadequately controlled with metformin: a Bayesian network meta-analysis
Leqing Xu, Yike Wu, Jiyifan Li, Yanan Ding, Junwei Chow, Longzhou Li, Haiyang Liu, Zihan Wang, Tingting Gong, Yue Li, Guo Ma
BMJ Open.2025; 15(2): e088687. CrossRef - Reverse translational approach to clarify the strong potency of enavogliflozin, a novel sodium-glucose cotransporter 2 inhibitor
Sun-Hwa Park, Hye-Young Ji, Ji-Soo Choi, Kyung Seok Oh, Jihoon Lee, Minyeong Pang, Im-Sook Song, Joon Seok Park
The Journal of Pharmacology and Experimental Therapeutics.2025; 392(8): 103650. CrossRef - Combined effects of Yupingfeng and metformin on blood glucose levels and intestinal tissue in high-fat diet-induced type 2 diabetic rats
Hui Liu, Yuan Guan, Like Xu, Ji Hu
Frontiers in Endocrinology.2025;[Epub] CrossRef - Comparison of safety profile of DPP4 inhibitors with SGLT2 inhibitors in type 2 diabetes mellitus: systematic review
Zeel R. Nimavat, Ankit N. Patel, Alpa P. Gor, Barna Ganguly
International Journal of Basic & Clinical Pharmacology.2025;[Epub] CrossRef - Weight-independent amelioration of adipokine profile by enavogliflozin, a selective SGLT2 inhibitor, in patients with type 2 diabetes
Young Sang Lyu, Hansol Lee, Kyung-Soo Kim, Sangmo Hong, Cheol-Young Park
Cardiovascular Diabetology.2025;[Epub] CrossRef - Pharmacokinetics and Safety of Fixed‐Dose Versus Separate Enavogliflozin/Gemigliptin Combinations, and Food Effect on Enavogliflozin in Healthy Korean Subjects
Young‐Sim Choi, JAEJIN NA, Seo Yeong Park, Jae Min Cho, Yoonhye Jeong, Jun Gi Hwang
Clinical and Translational Science.2025;[Epub] CrossRef - Inhibitors of sodium-glucose cotransporter: When wasting fuel is sought and beneficial to health
Francois Alhenc-Gelas
The Journal of Pharmacology and Experimental Therapeutics.2025; 392(11): 103742. CrossRef - Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials
Young Sang Lyu, Sangmo Hong, Si Eun Lee, Bo Young Cho, Cheol-Young Park
Cardiovascular Diabetology.2024;[Epub] CrossRef - A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: ENHANCE‐M extension study
Tae Seo Sohn, Kyung‐Ah Han, Yonghyun Kim, Byung‐Wan Lee, Suk Chon, In‐Kyung Jeong, Eun‐Gyoung Hong, Jang Won Son, JaeJin Na, Jae Min Cho, Seong In Cho, Wan Huh, Kun‐Ho Yoon
Diabetes, Obesity and Metabolism.2024; 26(6): 2248. CrossRef - The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective sodium‐glucose cotransporter‐2 inhibitor, in type 2 diabetes
Sae Im Jeong, Mu Seong Ban, Jun‐Gi Hwang, Min‐Kyu Park, Soo Lim, Sejoong Kim, Soon Kil Kwon, Yoonjin Kim, Jae Min Cho, Jae Jin Na, Wan Huh, Jae‐Yong Chung
Diabetes, Obesity and Metabolism.2024; 26(7): 2588. CrossRef - Long‐term efficacy and safety of enavogliflozin in Korean people with type 2 diabetes: A 52‐week extension of a Phase 3 randomized controlled trial
Soo Heon Kwak, Kyung Ah Han, Eun Sook Kim, Sung Hee Choi, Jong Chul Won, Jae Myung Yu, Seungjoon Oh, Hye Jin Yoo, Chong Hwa Kim, Kyung‐Soo Kim, SungWan Chun, Yong Hyun Kim, Seung Ah Cho, Da Hye Kim, Kyong Soo Park
Diabetes, Obesity and Metabolism.2024; 26(10): 4203. CrossRef - Role of novel sodium glucose co-transporter-2 inhibitor enavogliflozin in type-2 diabetes: A systematic review and meta-analysis
Deep Dutta, B.G. Harish, Beatrice Anne, Lakshmi Nagendra
Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(8): 102816. CrossRef - Characteristics of the Latest Therapeutic Agent for Diabetes
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The Journal of Korean Diabetes.2023; 24(3): 148. CrossRef - Prospects of using sodium-glucose co-transporter-2 (SGLT-2) inhibitors in patients with metabolic-associated fatty liver disease (MAFLD)
Iryna Kostitska, Nadia Protas, Liliia Petrovska
Diabetes Obesity Metabolic Syndrome.2023; (5): 8. CrossRef - Navigating the Future of Diabetes Treatment with New Drugs: Focusing on the Possibilities and Prospects of Enavogliflozin
Sang Youl Rhee
Diabetes & Metabolism Journal.2023; 47(6): 769. CrossRef
- Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
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