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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2025-06-30

Brief Summary

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Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardiovascular and renal protection in patients with type 2 diabetes (T2D); however, the underlying mechanism remains unclear. We hypothesized that SGLT2 inhibitor will improve the ketone metabolism compared to dipeptidyl Peptidase-4 (DPP4) inhibitor. And we will also evaluate the association between ketone metabolism and cardiac remodeling evaluated by echocardiography. We will randomly assign 122 people with T2DM to receive dapagliflozin 10mg or gemigliptin 50mg. The primary endpoint are changes in acetoacetate, total ketone, beta-hydroxybutyric acid, left ventricular (LV) mass index, and LV global longitudinal strain during 6 months follow-up. This study may provide robust evidence of the thrifty substrate hypothesis for cardiovascular protection of SGLT2 inhibitors.

Detailed Description

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Conditions

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Type2 Diabetes Remodeling, Ventricular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dapagliflozin group

Dapagliflozin 10mg for 6 months.

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.

Gemigliptin group

Gemigliptin 50mg for 6 months.

Group Type PLACEBO_COMPARATOR

Gemigliptin

Intervention Type DRUG

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.

Intervention Type DRUG

Gemigliptin

The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with T2D on stable antidiabetic medication
* No recent use of SGLT2 inhibitor within 3 months

Exclusion Criteria

* HbA1c \> 10%
* Pregnancy or breast feeding
* estimated GFR \<45 30 mL/min/1.73㎡
* insulin user
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Hyuk Cho

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yonsei University Wonju College of Medicine

Wŏnju, Gangwondo, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Hyuk Cho, MD,PhD

Role: CONTACT

82-33-741-0916

Facility Contacts

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Dong-Hyuk Cho, MD

Role: primary

82-33-741-0916

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.

Reference Type BACKGROUND
PMID: 32943171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25271206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30132036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32358544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33648515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32578850 (View on PubMed)

Other Identifiers

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CR121038

Identifier Type: -

Identifier Source: org_study_id

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