Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes

NCT03887416 | Unknown Phase 4 DMC

• 2 other identifiers: DAPA-ESR-16-124602017-002125-38
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 3

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.

Conditions

Type2 Diabetes

Keywords

Nighttime blood pressure; Dapagliflozin

Outcome Measures

Primary Outcomes (1)

• Changes in nighttime blood pressure

  Changes in mean nighttime blood pressure (systolic and diastolic) between baseline and last visit (units: mmHg)

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

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)

Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga]

Placebo matching dapagliflozin

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

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)

Also known as: Dapagliflozin

Dapagliflozin

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

Also known as: Placebo

Placebo matching dapagliflozin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a previous diagnosis of type 2 diabetes and
• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min x1.73m2and
• HbA1C 7.5-10%
• Albuminuria levels ≥ 30 mg/g of creatinine

You may not qualify if:

• 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.)

Sponsors & Collaborators

• LM Diagnósticos S.L.: lead
• AstraZeneca: collaborator

Study Sites (3)

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (24)

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MeSH Terms

Interventions

dapagliflozin; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Luis M Ruilope Urioste

  Hospital Universitario 12 de Octubre de Madrid

  STUDY DIRECTOR

Central Study Contacts

Luis M Ruilope Urioste

CONTACT

629175770; ruilope@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Type of study: Randomized, multicentric, placebo-controlled, single-blind pilot study. 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 Record Dates

• First Submitted: March 8, 2019
• First Posted: March 25, 2019
• Study Start: April 12, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)