Effect of dapagliflozin on nighttime blood pressure in type 2 diabetes

Phase 1

• Conditions: Patients with diabetes and high blood pressure; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002125-38-ES
• Lead Sponsor: M Diagnósticos S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Patients with a previous diagnosis of type 2 diabetes and
- Estimated glomerular filtration rate (eGFR) > 30mL/min x1,73m2and
- Diagnosis of essential hypertension established at least one year before inclusion visit and suboptimal BP control (office BP above 140/70 mmHg)
- HbA1C 7.5-10%
- Albuminuria levels = 30 mg/g of creatinine
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

- Age < 18 years old or = 75 years old.
- Women of childbearing potential
- Type 1 diabetes
- Albuminuria above 3000 mg/g of creatinine
- Established cardiovascular disease (stable heart failure, peripheral arterial disease or myocardial infarction or stroke within the previous 6 months)
- Intolerance to dapagliflozin
- On treatment with loop diuretic
- Patients who routinely work during nightime (period between 11.00 p.m. and 7.00 a.m.)

Study & Design

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