The cardiovascular effects of ertugliflozin in patients with type 2 diabetesand heart failure.

Phase 1

• Conditions: Diabetes Mellitus Type 2 and Heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001840-37-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Male or female subjects diagnosed with T2D =12 months prior to
informed consent;
2. eGFR =30 ml/min/1.73m2;
3. Age >18 years;
4. HbA1c 6.5%-10.5%;
5. Body Mass Index (BMI) 18.5-45.0 kg/m2;
6. Blood pressure < 160/110 and > 90/60 at screening,
7. Heart failure with New York Heart Association (NYHA) class 2-3 symptoms and ejection fraction > 20%
8. Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
9. Stable diuretic dose for at least 30 days at the time of baseline physiological assessment
10. BNP levels at baseline > 100 pg/ml (no atrial fibrillation), > 200 pg/ml if in atrial fibrillation (if NT-pro-BNP is used then baseline should be >300 ng/L (no atrial fibrillation), or >600 ng/L (in atrial fibrillation)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Type 1 Diabetes;
2. Leukocyte and/or nitrite positive urinalysis that is untreated;
3. Severe hypoglycaemia within 2 months prior to screening;
4. History of brittle diabetes or hypoglycaemia unawareness based on investigator judgement;
5. Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;
6. Clinically significant valvular disease;
7. Congestive heart failure secondary to an infiltrative cardiomyopathic process (for example amyloid) or pericardial constriction;
8. Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure >110) or systemic hypotension
(systolic blood pressure < 90/60 mmHg);
9. Bariatric surgery or other surgeries that induce chronic malabsorption;
10. Anti-obesity drugs or diet regimen and unstable body weight three months prior to screening;
11. Treatment with systemic corticosteroids;
12. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
13. Pre-menopausal women who are nursing, pregnant, or of childbearing potential and not practicing an acceptable method of birth
control;
14. Participation in another trial with an investigational drug within 30 days of informed consent;
15. Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical
condition that would jeopardize subject safety or study compliance based on investigator judgement;
16. Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of
normal as determined during screening;
17. Active malignancy at the time of screening;
18. Allergy to iodine-based substances if receiving iohexol for GFR measures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified