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

Part of paid clinical trials in Metairie, Louisiana.

Sponsor
Gulf Regional Research & Educational Services, LLC
Study ID
NCT02372955
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    subjects will be randomly assigned to receive dapagliflozin 10 mg daily
  • glimpiride — DRUG
    subjects will be randomly assigned to receive glimpiride 4 mg daily

Study Details

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 Dates

Start date
Feb 28, 2015
Status verified
Feb 2015
Primary completion
Feb 29, 2016
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: dapagliflozin 10 mg daily
    dapagliflozin, 10 mg daily for 16 weeks
  • Active Comparator: glimpiride
    glimpiride 4 mg daily for 16 weeks

Primary Outcome Measure

systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gulf Regional Research & Educational Services, LLCMetairieLouisiana70002
Thomas D Giles, MD
[email protected]
504-834-8668
Louise E Roffidal, BSN, MPH
[email protected]
504.220.6275

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Gulf Regional Research & Educational Services, LLC· Metairie, LA

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