Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus-type-2
Started Feb 2015
Typical duration for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 26, 2015
February 1, 2015
1 year
January 7, 2015
February 20, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
16 weeks
arterial stiffness
arterial stiffness will be assessed by measuring aortic pulse wave velocity (aPWV) and augmentation index
16 weeks
Secondary Outcomes (2)
urinary sodium excretion
16 weeks
composite intravascular volume status
16 weeks
Study Arms (2)
dapagliflozin 10 mg daily
EXPERIMENTALdapagliflozin, 10 mg daily for 16 weeks
glimpiride
ACTIVE COMPARATORglimpiride 4 mg daily for 16 weeks
Interventions
subjects will be randomly assigned to receive dapagliflozin 10 mg daily
subjects will be randomly assigned to receive glimpiride 4 mg daily
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gulf Regional Research & Educational Services, LLC
Metairie, Louisiana, 70002, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
January 7, 2015
First Posted
February 26, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
December 1, 2016
Last Updated
February 26, 2015
Record last verified: 2015-02