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

Primary Purpose

Type2 Diabetes, Remodeling, Ventricular

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin
Gemigliptin
Sponsored by
Wonju Severance Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University Wonju College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapagliflozin group

Gemigliptin group

Arm Description

Dapagliflozin 10mg for 6 months.

Gemigliptin 50mg for 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change (%) in LV ejection global longitudinal strain
The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
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

Full Information

First Posted
January 4, 2022
Last Updated
July 30, 2023
Sponsor
Wonju Severance Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05194592
Brief Title
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Official Title
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonju Severance Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Remodeling, Ventricular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin group
Arm Type
Active Comparator
Arm Description
Dapagliflozin 10mg for 6 months.
Arm Title
Gemigliptin group
Arm Type
Placebo Comparator
Arm Description
Gemigliptin 50mg for 6 months.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
The patients assigned to the Dapagliflozin group will take Farxiga Pill 10mg for 6 months.
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Intervention Description
The patients assigned to the Gemigliptin group will take Zemiglo Pill 50mg for 6 months.
Primary Outcome Measure Information:
Title
Change (%) in acetoacetate, total ketone, beta-hydroxybutyric acid
Description
The change of acetoacetate, total ketone, beta-hydroxybutyric acid from baseline to 6 months follow-up
Time Frame
6 months
Title
Change (%) in LV mass index
Description
The change of LV mass index from baseline to 6 months follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change (%) in LV ejection global longitudinal strain
Description
The change of LV mass ejection global longitudinal strain from baseline to 6 months follow-up
Time Frame
6 months
Title
Change (%) in mean 24hr ambulatory systolic and diastolic blood pressure
Description
The change of mean 24hr ambulatory systolic and diastolic blood pressurefrom baseline to 6 months follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Hyuk Cho, MD,PhD
Phone
82-33-741-0916
Email
why012@gmail.com
Facility Information:
Facility Name
Yonsei University Wonju College of Medicine
City
Wonju
State/Province
Gangwondo
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Hyuk Cho, MD
Phone
82-33-741-0916
Email
why012@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32943171
Citation
Correction. J Am Coll Cardiol. 2020 Sep 22;76(12):1505. doi: 10.1016/j.jacc.2020.08.010. No abstract available.
Results Reference
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PubMed Identifier
25271206
Citation
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.
Results Reference
background
PubMed Identifier
30132036
Citation
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.
Results Reference
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PubMed Identifier
32358544
Citation
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.
Results Reference
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PubMed Identifier
33648515
Citation
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.
Results Reference
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PubMed Identifier
32578850
Citation
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.
Results Reference
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Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

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