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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gulf Regional Research & Educational Services, LLC
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Type 2 diabetes mellitus

• Metformin treatment

Exclusion Criteria:

• • 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