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Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes

NCT03887416 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2019-09-03

No results posted yet for this study

Summary

Centres: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre) Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study Main outcome: Nighttime blood pressure in type 2 diabetic patients Objective: To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients withalbuminuria levels ≥ 30 and \< 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2..

Patients: 225 patients with a previous diagnosis of type 2 diabetes and eGFR\> 30mL/min x1,73m2, office BP above 140/70 mmHg, HbA1C 7.5-10%, albuminuria levels between 30 mg/g creatinine and 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.

Intervention: 10 mg once daily of dapagliflozin or placebo resembling dapagliflozin.

Conditions

  • Type2 Diabetes

Interventions

DRUG

Dapagliflozin 10 MG Oral Tablet [Farxiga]

The investigational medicinal product (IMP) is dapagliflozin10 mg given once daily (film coated tablets, oral use). Dapagliflozin will be administered through out the planned intervention period of the study (12 weeks). Dosage form and strength: 10 mg, Green, plain, diamond shaped, film coated tablet (orally)

DRUG

Placebo Oral Tablet

The comparator will be placebo oral tablet matching dapagliflozin 10 mg. Placebo will be administered through out the planned intervention period of the study (12 weeks). Dosage form and strength: Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • LM Diagnósticos S.L.

    lead OTHER

Principal Investigators

  • Luis M Ruilope Urioste · Hospital Universitario 12 de Octubre de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Spain

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887416 on ClinicalTrials.gov