This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo (benefit/risk and ethical assessment) and its effects on arterial stiffness and urine albumin excretion in patients with type 2 diabetes.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2015-005288-17-GR
• Date of registration: 17/03/2016
• Prospective Registration: Yes
• Primary sponsor: ???????? ???????? ???????S ????????S?S (Hellenic Society of Medical Education)
• Public title: This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo (benefit/risk and ethical assessment) and its effects on arterial stiffness and urine albumin excretion in patients with type 2 diabetes.
• Scientific title: A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes. - DAPA
• Date of first enrolment: 05/04/2016
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005288-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Greece

Contacts

• Name: Head of Clinical Operations
• Affiliation: CREATIVE PHARMA SERVICES S.A.

• Name: Head of Clinical Operations
• Affiliation: CREATIVE PHARMA SERVICES S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age >18 and <70 years old
2. Type 2 diabetes mellitus
3. Glycated hemoglobin >7% and <9%
4. Patients on stable dose of metformin of at least 1500 mg for the past 3 months.
5. Patient to provide informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Hypovolemic patients.
2. Patients on loop diuretics.
3. Patients with low BP (office SBP <110 mmHg) or orthostatic hypotension (BP drop >20 mmHg and SBP <110 mmHg in standing position at 1 min).
4. Patients on antidiabetic drugs other than metformin.
5. Secondary hypertension.
6. Stage 2 hypertension or higher (office SBP =160 mmHg or DBP =100 mmHg).
7. Chronic kidney disease stage 3 or higher (GFR<60 mL/min/1.73 m2).
8. Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria.
9. Pregnancy or childbearing potential [defined as women which have entered menses and are not post-menopausal (menopause is defined as the absence of menses for at least 12 months without any other medical cause in women of typical age) or women that have been subjected to permanent sterilization (ie. tubal ligation, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)].
10. History of liver disease or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL.
11. History of malignancy of any organ system (resected basal cell carcinoma considered cured is exempted) within the past 5 years prior to Visit 1 (V1).
12. History of drug or alcohol abuse within the last one year.
13. Any contraindication or history of hypersensitivity to the study drug or to drugs with similar chemical structures.
14. Any other surgical or medical condition that, in the opinion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
15. Intake of an investigational drug in another trial within 30 days prior to Visit 1 (V1).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes mellitus.
MedDRA version: 18.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Forxiga
Product Name: FORXIGA
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary endpoint will be recorded with Mobil-O-Graph for the period between visit 1 and end of study (12 weeks treatment)

Secondary Objective: Secondary objectives are to investigate the effects of dapagliflozin on ambulatory arterial stiffness, and urine albumin excretion.

Main Objective: The main objective of the present study is to investigate the effect of dapagliflozin on ambulatory aortic pressure in patients with type 2 DM.

Primary end point(s): The difference between the groups of dapagliflozin and placebo in the change of 24-hour systolic aortic pressure at study-end

Secondary Outcome(s)

Secondary end point(s): Secondary end-points would include the difference between the groups of dapagliflozin and placebo in the change of the following parameters between visit 1 and end of study (12 weeks treatment):
1. 24-hour central aortic DBP.
2. 24-hour brachial SBP and DBP.
3. 24-hour AIx.
4. 24-hour PWV.
5. Office brachial SBP and DBP.
6. Albumin/creatinine ratio (ACR).
7. Lipid profile (Total-Cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides).
8. HbA1c.

Timepoint(s) of evaluation of this end point: Period between visit 1 and end of study (12 weeks treatment)

Secondary ID(s)

ESR-15-10964

Source(s) of Monetary Support

???????? ???????? ???????S ????????S?S (Hellenic Society of Medical Education)

Ethics review

Status: Approved
Approval date:
Contact: