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.

A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes. - DAPA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005288-17-GR

Enrollment

160

Registered

2016-03-17

Start date

2016-04-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 18.1 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 disord

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 and 7% and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Hypovolemic patients. 2. Patients on loop diuretics. 3. Patients with low BP (office SBP 20 mmHg and SBP 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).

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Greece

Contacts

Public ContactHead of Clinical Operations

CREATIVE PHARMA SERVICES S.A.

dtsapoga@creativephs.com00302103259350

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026