Coronary Artery Disease, Type 2 Diabetes
Conditions
Keywords
CAD., T2DM., LVEF%., Sortilin., Empaglilozin., Vildagliptin.
Brief 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).
Detailed description
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.
Interventions
DRUGEmpagliflozin 10 MG
eligible subjects were randomly and equally assigned to the empagliflozin add-on group (empagliflozin 10 mg/ day).
eligible subjects were randomly and equally assigned to vildagliptin add-on group (vildagliptin 50 mg/day as the initial dose).
Sponsors
Tanta University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEF % | 6 months | echocardiographic measurements |
| Sortilin (ng/ml) | 6 months | Serum Biomarkers |
| LDL (mg/dl) | 6 months | Lipid profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP (mg/L) | 6 months | Serum Biomarkers |
| HbA1c % | 6 months | Glycemic control |
| FBG (mg/dl) | 6 Months | Serum level |
Countries
Egypt
Outcome results
None listed