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

July 30, 2023 updated by: Dong-Hyuk Cho, Wonju Severance Christian Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dong-Hyuk Cho, MD,PhD
  • Phone Number: 82-33-741-0916
  • Email: why012@gmail.com

Study Locations

  • Korea, Republic of
    • Gangwondo
      • Wonju, Gangwondo, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University Wonju College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dapagliflozin group
Dapagliflozin 10mg for 6 months.
Drug: Dapagliflozin
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
Placebo Comparator: Gemigliptin group
Gemigliptin 50mg for 6 months.
Drug: Gemigliptin
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
Time Frame: 6 months
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
6 months
Change (%) in LV mass index
Time Frame: 6 months
The change of LV mass index from baseline to 6 months follow-up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (%) in LV ejection global longitudinal strain
Time Frame: 6 months
The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
6 months
Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure
Time Frame: 6 months
The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR121038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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