Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes

Status unconfirmed · Phase 4

Conditions studied: Diabetes Mellitus Type 2

In brief

Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is unknown. The primary objective of the study is to determine the effect of dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and Intravascular volume status will be recorded. The study will involve 21 subjects for a duration of 16 weeks.

Key facts

Study ID

NCT02372955

Run by

Gulf Regional Research & Educational Services, LLC

People needed

21

Starts

2015-02-01

Expected to finish

2016-12-01

Last updated by the study team

2015-02-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus
• Metformin treatment

You may not qualify if…

• • Type 1 diabetes mellitus
• Hgb A1c > 9
• Advanced diabetic complications, e.g. diabetic renal disease (eGFR < 60 cc/min), heavy proteinuria, diabetic retinopathy, autonomic neuropathy
• Pregnancy or unwilling to practice contraception.
• Uncontrolled hypertension (SBP > 150 mm Hg; DBP > 100 mm Hg)
• Chronic substance abusers
• Carcinoma of the urinary bladder
• Subjects deemed at risk for dehydration

Where it is running

• Gulf Regional Research & Educational Services, LLC — Metairie, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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