Effects of Dapagliflozin on Inflammatory Factorslevel and Prognosis in Type 2 Diabetes With Acute Myocardial Infarction

Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.

1. Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829.
2. Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Glucose Intolerance; Diabete Type 2
• Intervention / Treatment: Drug: Dapagliflozin 10mg/Tab; Drug: control group

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266042
      • Mengmei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
2. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Exclusion Criteria:

1. Patients diagnosed with Type 1 Diabetes Mellitus.
2. Patients with renal dysfunction. (GFR<90mmol/L).
3. Patients who have recently undergone immunosuppressive therapy.
4. Patients with a history of recurrent urinary tract infections.
5. Patients who are known to be allergic to SGLT-2 inhibitors.
6. Patients who are hemodynamically unstable.
7. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
9. Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Dapagliflozin 10 mg every 24 hours for 12 months	Drug: Dapagliflozin 10mg/Tab; patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months; Other Names: Dapagliflozin Group
Other: Control Group; AMI standard therapy for 12 months	Drug: control group; patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE events	To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.	12 months
Post-infarction angina	Evaluate the post-infarction angina occurence in both groups	12 months
The rate of heart failure occurrence	Assess the rate of new-onset heart failure during the study follow-up.	12 months
IL-6	Serum IL-6 level	baseline, 1 month, 3 month, 6 month, 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-1β	Serum IL-1β	baseline, 1 month, 3 month, 6 month, 12 month
hs-CRP	hs-CRP	baseline, 1 month, 3 month, 6 month, 12 month

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital
• Investigators: Study Director: Weisheng Liu, MD, Qingdao Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: myocardial infarction; dapagliflozin; MACE events
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Hyperglycemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Myocardial Infarction; Glucose Intolerance; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups; dapagliflozin
• Other Study ID Numbers: DAFLO-CH; DAFLO (Registry Identifier: DAFLO-CH)

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes