Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 225
- Locations
- 3
- Primary Endpoint
- Changes in nighttime blood pressure
Study Overview
Brief 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.
Detailed Description
Effect of dapagliflozin on nighttime blood pressure in type 2 diabetes
TYPE OF STUDY: Randomized, multicentric, placebo-controlled, single-blind pilot study.
CENTRES: Three university hospitals and the primary care centres in their area in Madrid (Clínico San Carlos, La Paz, 12 de Octubre)
PRIMARY 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 with albuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a previous diagnosis of type 2 diabetes and
- •Estimated glomerular filtration rate (eGFR) ≥ 60 mL/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
Exclusion Criteria
- •Age < 18 years old or ≥ 75 years old.
- •Women of childbearing potential. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •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
- •On treatment with SGLT2 inhibitors.
- •On treatment with pioglitazone.
- •Patients diagnosed of hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Patients who routinely work during nightime (period between 11.00 p.m. and 7.00 a.m.)
Arms & Interventions
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)
Intervention: Dapagliflozin 10 MG Oral Tablet [Farxiga] (Drug)
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
Intervention: Placebo Oral Tablet (Drug)
Outcomes
Primary Outcomes
Changes in nighttime blood pressure
Time Frame: 12 weeks
Changes in mean nighttime blood pressure (systolic and diastolic) between baseline and last visit (units: mmHg)
Secondary Outcomes
- Changes in office blood pressure. Both systolic and diastolic blood pressure will be assessed(12 weeks)
- Changes in albuminuria(12 weeks)
- Changes in HBA1C(12 weeks)