Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease

NCT03398577 | Unknown Phase 4

• 1 other identifier: SGLT2
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore the effect of newly added SGLT2I medication or placebo, to standard medication regimen in diabetic patients with documented stable coronary disease. Therefore, in the present study the investigators plan to focus on possible anti-inflammatory and athero-thrombotic protective effects of Dapagliflozin compared to placebo, in secondary prevention population of stable coronary patients with diabetes. Additionally, the investigators will explore NT proBNP dynamics, which related to ventricular filling pressures in this specific population.

Conditions

Coronary Disease With Diabetes Mellitus

Keywords

Coronary disease; diabetes; SGLT2I; Inflammation Mediators

Outcome Measures

Primary Outcomes (1)

• Percent reduction in interleukin (IL)-1β levels

  Percent reduction in IL-1 β will be calculated as follows:(Baseline IL-1 minus follow-up \[3-month\] IL-1)/Baseline IL1; with value multiplied by 100.

  3 months

Secondary Outcomes (7)

• Percent reduction in additional biomarkers

  3 months

• Safety from events of clinical hypoglycemia

  3 Months

• Reduction in BMI

  3 Months

• Reduction in HB A1c

  3 Months

• NTpro BNP

  3 Months

Study Arms (2)

Intervention group

EXPERIMENTAL

Eligible patients (HbA1C ≥ 7% and ≤ 9%) , who were allocated to the Intervention group will receive Dapagliflozin 10 mg in addition to oral anti-diabetic medication administered prior to study enrollment.

Drug: Dapagliflozin 10 MG [Farxiga]

Control group

PLACEBO COMPARATOR

Eligible patients (HbA1C ≥ 7% and ≤ 9%) , who were allocated to the Control group will receive placebo in addition to oral anti-diabetic medication administered prior to study enrollment.

Drug: Placebo Oral Tablet

Interventions

Dapagliflozin 10 MG [Farxiga] DRUG

Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.

Also known as: Farxiga

Intervention group

Placebo Oral Tablet DRUG

Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus on oral therapy
• Stable documented ischemic Heart disease (\> 60 days post AMI, CABG or PCI)
• Sub-optimal Hb A1c defined as ≥ 7%
• Age \> 21
• Life expectancy \>1 year

You may not qualify if:

• Events of clinical hypoglycemia during the past 6 months
• Recent (\< 60 days) acute coronary syndrome (ACS) or Cerebrovascular accident
• Transient ischemic attack (TIA) within the past year.
• Significant renal impairment (eGFR \< 60 ml/min/1.73 m2)
• History of recurrent UTI \\ vaginitis
• Past bladder cancer (TCC or other)
• History of diabetic keto-acidosis
• Planned coronary intervention or planed surgical intervention (PCI or CABG)
• Unstable arrhythmias (i.e. rapid atrial fibrillation, symptomatic bradycardia, recurrent ventricular arrhythmia that are clinically significant, etc.)
• Known hypersensitivity to study drug
• Type I diabetes
• Current Hb A1c \>9%
• Current Insulin treatment
• Active treatment with SGLT2I medication
• Inability to comply with study protocol

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center, Cardiac Rehabilitation Institute

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Robert Klempfner, Proffesor

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gal Shmukler, MA

CONTACT

+972-3-5344703; Gal.Shmukler@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor Robert Kempfner

Model Details: The study is designed as a single-center, double-blinded, placebo controlled, 2-arm clinical trial to provide evidence on the effects of Dapagliflozin on key biomarkers of athero-thrombosis, inflammation and ventricular loading conditions (NT ProBNP).

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 12, 2018
• Study Start: February 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

IL (1)