Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

Coronary Artery Disease Clinical Trial

Official title:

A Clinical Study Comparing Effects of Empagliflozin Versus Vildagliptin on Inflammatory Biomarkers, and Atrial Function in Coronary Artery Disease Patients With Type 2 Diabetes: EMBA-VILDA-Response Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313008
• Other study ID #: EMBA-VILDA-Response trial.
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: April 2024
• Source: Damanhour University
• Contact: Rehab H Werida, Ass. Prof.
• Phone: 01005359968
• Email: rehabwrieda[@]pharm.dmu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM).

Description:

This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 12-week administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. The randomization list was produced using an automated random number generator. Clinical parameters, assessment of atrial myocardial function, LVEF%, LA diameter, glycemic and lipid profile, adiponectin, high-sensitivity C-reactive protein, and Sortilin levels will be determined at baseline and after the 6 months of treatment period. Patient compliance was evaluated by the counting of pills by a physician at selected time-points. In addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. These cards were checked regularly by site staff. The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments. All included patients provided written informed consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 10, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. T2DM patients with chronic stable angina.

2. patients with glycated hemoglobin (HbA1c) levels of 6.0-10.0%.

3. patients aged 20-80 years.

4. patients with a body mass index of = 22 kg/m2.

5. patients who provided written informed consent.

Exclusion Criteria:

1. patients with type 1 diabetes mellitus or secondary diabetes mellitus.

2. patients with renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2).

3. patients with left ventricular ejection fraction (LVEF) < 30%.

4. patients with untreated cancer.

5. patients with hepatic cirrhosis.

6. patients with liver failure that was virus-, autoimmune- or drug-induced.

7. patients with alcoholism.

8. pregnant or breastfeeding patients, or those planning to become pregnant during the course of the study.

9. patients allergic to empagliflozin or vildagliptin.

10. patients with anemia (hemoglobin < 12 g/dL).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Drug:
• Empagliflozin 10 MG
eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
• Vildagliptin 50 MG
eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).

Locations

Country	Name	City	State
Egypt	Rehab Hussein Werida	Damanhur	Elbehairah

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Naing S, Poliyedath A, Khandelwal S, Sigala T. Impact of EMPA-REG OUTCOME(R) on the management of type 2 diabetes mellitus: a review for primary care physicians. Postgrad Med. 2016 Nov;128(8):822-827. doi: 10.1080/00325481.2016.1245093. Epub 2016 Oct 25. — View Citation

Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH. EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus. Clin Ther. 2016 Jun;38(6):1288-1298. doi: 10.1016/j.clinthera.2016.04.037. Epub 2016 May 19. — View Citation

Shimizu W, Kubota Y, Hoshika Y, Mozawa K, Tara S, Tokita Y, Yodogawa K, Iwasaki YK, Yamamoto T, Takano H, Tsukada Y, Asai K, Miyamoto M, Miyauchi Y, Kodani E, Ishikawa M, Maruyama M, Ogano M, Tanabe J; EMBODY trial investigators. Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial. Cardiovasc Diabetol. 2020 Sep 25;19(1):148. doi: 10.1186/s12933-020-01127-z. — View Citation

Tanaka A, Shimabukuro M, Okada Y, Taguchi I, Yamaoka-Tojo M, Tomiyama H, Teragawa H, Sugiyama S, Yoshida H, Sato Y, Kawaguchi A, Ikehara Y, Machii N, Maruhashi T, Shima KR, Takamura T, Matsuzawa Y, Kimura K, Sakuma M, Oyama JI, Inoue T, Higashi Y, Ueda S, Node K; EMBLEM Trial Investigators. Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial. Cardiovasc Diabetol. 2017 Apr 12;16(1):48. doi: 10.1186/s12933-017-0532-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVEF %	echocardiographic measurements	6 months
Primary	Sortilin (ng/ml)	Serum Biomarkers	6 months
Primary	LDL (mg/dl)	Lipid profile	6 months
Secondary	hsCRP (mg/L)	Serum Biomarkers	6 months
Secondary	HbA1c %	Glycemic control	6 months
Secondary	FBG (mg/dl)	Serum level	6 Months