AzTrials
AzTrials

Type2 DiabetesPhase 4NCT05194592

Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

A Phase 4 study testing Dapagliflozin and Gemigliptin in people with Type2 Diabetes and Remodeling, Ventricular, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Type2 Diabetes, Remodeling, Ventricular
What is being tested?
Dapagliflozin and Gemigliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
1 siteSouth Korea
Study dates
7 Jan 2022to 30 Jun 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • HbA1c > 10%
  • Pregnancy or breast feeding
  • estimated GFR <45 30 mL/min/1.73㎡
  • insulin user

Trial locations and contacts

1 site in 1 country.

Dong-Hyuk Cho, MD,PhD contact

82-33-741-0916

why012@gmail.com

South Korea1 site, 1 recruiting

  • Yonsei University Wonju College of Medicine

    Wŏnju, Gangwondo, 26426

    Dong-Hyuk Cho, MD, 82-33-741-0916, why012@gmail.com

    Recruiting

Other trials in South Korea

About this study

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.

Being tested
Dapagliflozin, Gemigliptin
Medical subject headings
Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

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

  • GemigliptinDrug

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

Study groups in NCT05194592
Study groupRoleWhat they receive
Dapagliflozin groupActive comparatorDapagliflozin 10mg for 6 months.
Receives: Drug: Dapagliflozin
Gemigliptin groupPlacebo comparatorGemigliptin 50mg for 6 months.
Receives: Drug: Gemigliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid

    The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up

    Measured: 6 months

  2. Change (%) in LV mass index

    The change of LV mass index from baseline to 6 months follow-up

    Measured: 6 months

Secondary outcomes (2)

  1. Change (%) in LV ejection global longitudinal strain

    The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up

    Measured: 6 months

  2. Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure

    The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start7 Jan 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194592
Sponsor's protocol ID
CR121038
Status last verified
Jul 2023
First submitted
4 Jan 2022
Last updated
1 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Correction. J Am Coll Cardiol. 2020 Sep 22;76(12):1505. doi: 10.1016/j.jacc.2020.08.010. No abstract available.

    PubMed 32943171

  • 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.

    PubMed 25271206

  • 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.

    PubMed 30132036

  • 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.

    PubMed 32358544

  • 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.

    PubMed 33648515

  • 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.

    PubMed 32578850

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin and Gemigliptin in people with Type2 Diabetes and Remodeling, Ventricular, run by Wonju Severance Christian Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dong-Hyuk Cho, MD,PhD (82-33-741-0916, why012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194592, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in