Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
NCT ID: NCT02372955
Last Updated: 2015-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
21 participants
INTERVENTIONAL
2015-02-28
2016-12-31
Brief Summary
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Detailed Description
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Dapagliflozin may have a favorable effect on vascular stiffness by a reduction in blood glucose resulting in decreased proximal arterial collagen cross-linking due to non-enzymatic glycosylation of proteins.
Dapagliflozin may also have a favorable effect on vascular stiffness by increasing urinary sodium excretion. Dapagliflozin is a sodium/glucose co-transporter inhibitor and the effects on sodium excretion are not clear. Increased sodium intake is associated with an increase in vascular stiffness.
An increase in vascular stiffness has been correlated with increased cardiovascular morbidity and mortality. Thus, it is important to know if dapagliflozin has an effect on vascular stiffness.
The current "gold standard" for vascular stiffness is aortic pulse wave velocity (aPWV). Other measures of vascular stiffness include: systolic blood pressure, pulse pressure and augmentation index. Also, measurement of calculated central blood pressure provides information that may not be apparent from measurement of brachial blood pressure.
Measures of intravascular volume status include: body weight, jugular venous pressure, orthostatic changes in blood pressure and heart rate.
It is important to recognize that some oral anti-diabetic drugs, e.g. sulfonylurea's are associated with an increase in systemic arterial blood pressure.
Hypothesis
That treatment of type 2 diabetes mellitus with dapagliflozin will result in a decrease in arterial stiffness
Primary Objectives
The primary objective of the study is to determine the effect of dapagliflozin (Appendix A), 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure.
Key Questions
* What effect will dapagliflozin have on measures of arterial stiffness?
* What effect will dapagliflozin have on central blood pressure?
* Will dapagliflozin lower BP over the 24-hour period and will the pattern of BP change?
* Will dapagliflozin increase sodium excretion for 16 weeks?
* What will be the effect of dapagliflozin on intravascular volume status at 16 weeks?
Secondary Objectives
* Urinary sodium excretion
* Intravascular volume status: jugular venous pressure, body weight, orthostatic change in BP and pulse rate
Treatment
All patients will receive a background treatment with metformin. After randomization (2:1) patients will receive dapagliflozin, 10 mg daily or glimpiride (Appendix B), 4 mg daily. The treatment period will last ;16 weeks.
For high risk subjects, dapagliflozin therapy will begin with 5 mg with up-titration at 2 weeks. High risk subjects are those prone to volume depletion and are identified by signs of hypovolemia, e.g. low venous pressure, and a low arteriasl blood pressure.
Subjects will also be closely monitored for the development of hypoglycemia. This risk will be minimized by not enrolling subjects taking insulin. Subjects will be made aware of the signs of hypotlycemia, e.g. sweating and palpitation, and will be instructed to treat with ingestion of sugar, particularly fructose in orange juice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dapagliflozin 10 mg daily
dapagliflozin, 10 mg daily for 16 weeks
dapagliflozin
subjects will be randomly assigned to receive dapagliflozin 10 mg daily
glimpiride
glimpiride 4 mg daily for 16 weeks
glimpiride
subjects will be randomly assigned to receive glimpiride 4 mg daily
Interventions
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dapagliflozin
subjects will be randomly assigned to receive dapagliflozin 10 mg daily
glimpiride
subjects will be randomly assigned to receive glimpiride 4 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metformin treatment
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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Gulf Regional Research & Educational Services, LLC
OTHER
Responsible Party
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Thomas Giles
Medical Director
Locations
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Gulf Regional Research & Educational Services, LLC
Metairie, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ESR-14-10022/D1690L00020
Identifier Type: -
Identifier Source: org_study_id
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