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Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

NCT ID: NCT06313008

Last Updated: 2024-11-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-10-10

Brief Summary

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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).

Detailed Description

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This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 6 months 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.

Conditions

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Coronary Artery Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a prospective, randomized, double-dummy, blinded-endpoint, parallel-group trial that enrolled 120 CAD patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Empagliflozin

Eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).

Vildagliptin

60 patients recieved vildagliptin as add-on group (vildagliptin 50 mg/day as the initial dose).

Group Type EXPERIMENTAL

Vildagliptin 50 MG

Intervention Type DRUG

eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).

Interventions

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Empagliflozin 10 MG

eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).

Intervention Type DRUG

Vildagliptin 50 MG

eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).

Intervention Type DRUG

Other Intervention Names

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Empa Vilda

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Werida

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lamiaa Khedr, Prof.

Role: STUDY_DIRECTOR

Tanta University

Locations

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Rehab Hussein Werida

Damanhūr, Elbehairah, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28403850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32977831 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27210264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27701934 (View on PubMed)

Other Identifiers

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EMBA-VILDA-Response trial.

Identifier Type: -

Identifier Source: org_study_id