Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes

Sponsor
LM Diagnósticos S.L.
Study ID
NCT03887416
Phase
PHASE4
Status
Unknown

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG Oral Tablet [Farxiga] — DRUG
    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)
  • Placebo Oral Tablet — DRUG
    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

Study Details

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.

Key Dates

Start date
Apr 12, 2019
Status verified
Mar 2019
Primary completion
Feb 29, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    The investigational medicinal product (IMP) is Dapagliflozin 10 MG Oral Tablet \[Farxiga\] given once daily (film coated tablets, oral use). Dapagliflozin 10 MG Oral Tablet \[Farxiga\] 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)
  • Placebo Comparator: Placebo matching dapagliflozin
    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

Primary Outcome Measure

Changes in nighttime blood pressure [ Time Frame: 12 weeks ]

Central Contacts

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