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.

Phase 1

• Conditions: 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: 18.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 18.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005288-17-GR
• Lead Sponsor: ???????? ???????? ???????S ????????S?S (Hellenic Society of Medical Education)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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).

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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. ;Secondary Objective: Secondary objectives are to investigate the effects of dapagliflozin on ambulatory arterial stiffness, and urine albumin excretion.;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;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 Outcome Measures

Name	Time	Method
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):<br>1.24-hour central aortic DBP.<br>2.24-hour brachial SBP and DBP.<br>3.24-hour AIx.<br>4.24-hour PWV.<br>5.Office brachial SBP and DBP.<br>6.Albumin/creatinine ratio (ACR).<br>7.Lipid profile (Total-Cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides).<br>8.HbA1c.<br>;Timepoint(s) of evaluation of this end point: Period between visit 1 and end of study (12 weeks treatment)