Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
NCT ID: NCT05194592
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
122 participants
INTERVENTIONAL
2022-01-07
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dapagliflozin group
Dapagliflozin 10mg for 6 months.
Dapagliflozin
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
Gemigliptin group
Gemigliptin 50mg for 6 months.
Gemigliptin
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Interventions
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Dapagliflozin
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
Gemigliptin
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Eligibility Criteria
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Inclusion Criteria
* No recent use of SGLT2 inhibitor within 3 months
Exclusion Criteria
* Pregnancy or breast feeding
* estimated GFR \<45 30 mL/min/1.73㎡
* insulin user
30 Years
80 Years
ALL
No
Sponsors
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Wonju Severance Christian Hospital
OTHER
Responsible Party
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Dong-Hyuk Cho
Assistant Professor
Locations
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Yonsei University Wonju College of Medicine
Wŏnju, Gangwondo, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Correction. J Am Coll Cardiol. 2020 Sep 22;76(12):1505. doi: 10.1016/j.jacc.2020.08.010. No abstract available.
Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.
Verma S, McMurray JJV. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia. 2018 Oct;61(10):2108-2117. doi: 10.1007/s00125-018-4670-7. Epub 2018 Aug 22.
Kim SR, Lee SG, Kim SH, Kim JH, Choi E, Cho W, Rim JH, Hwang I, Lee CJ, Lee M, Oh CM, Jeon JY, Gee HY, Kim JH, Lee BW, Kang ES, Cha BS, Lee MS, Yu JW, Cho JW, Kim JS, Lee YH. SGLT2 inhibition modulates NLRP3 inflammasome activity via ketones and insulin in diabetes with cardiovascular disease. Nat Commun. 2020 May 1;11(1):2127. doi: 10.1038/s41467-020-15983-6.
Gaborit B, Ancel P, Abdullah AE, Maurice F, Abdesselam I, Calen A, Soghomonian A, Houssays M, Varlet I, Eisinger M, Lasbleiz A, Peiretti F, Bornet CE, Lefur Y, Pini L, Rapacchi S, Bernard M, Resseguier N, Darmon P, Kober F, Dutour A. Effect of empagliflozin on ectopic fat stores and myocardial energetics in type 2 diabetes: the EMPACEF study. Cardiovasc Diabetol. 2021 Mar 1;20(1):57. doi: 10.1186/s12933-021-01237-2.
Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.
Other Identifiers
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CR121038
Identifier Type: -
Identifier Source: org_study_id
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