Effects of Canagliflozin on Intravascular Volume and Hemodynamics
NCT ID: NCT03190798
Last Updated: 2017-10-12
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2017-09-01
2018-08-01
Brief Summary
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* In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.
* Treatment with canagliflozin will be well tolerated over 4 weeks.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Canagliflozin Group
Assuming a 25% dropout rate, 16 individuals in the canagliflozin group
Canagliflozin 300mg
Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine.
Administered in 300mg tablets.
Placebo Group
Assuming a 25% dropout rate, 11 individuals in the placebo group
Placebo
Placebo for Canagliflozin
Interventions
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Canagliflozin 300mg
Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine.
Administered in 300mg tablets.
Placebo
Placebo for Canagliflozin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have an A1c ≥7% and ≤11%
* Estimated glomerular filtration rate (eGFR) must be ≥45 ml/min•1.73 m2
* have an NT-proBNP ≥500 pg/mL
* be on a stable dose of guideline-directed HF medication (i.e., angiotensin converting enzyme \[ACE\] inhibitor, angiotensin II receptor blocker \[ARB\], or angiotensin receptor neprilysin inhibitor \[ARNI\], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks
* be on stable antihypertensive therapy for at least 2 months
Exclusion Criteria
* repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose measurements ≥240 mg/dL or both
* during the pretreatment phase, NYHA Class IV HF status, uncontrolled hypertension as defined as systolic blood pressure (SBP) \>160 or diastolic blood pressure (DBP) \>100 mmHg
* liver disease (ALT or AST \>3 x ULN)
* anemia Hb\<10
* anticipated cardiac surgery or coronary intervention within the next 3 months
* severe unremediated valvular heart disease
* major CV event (e.g., MI, cerebrovascular accident) within 3 months prior to screening visit
* hospitalization for HF within 2 months prior to screening visit
* documented atrial fibrillation
* history of atraumatic amputation within past 12 months of screening or critical ischemia of the lower extremity within 6 months of screening
* an active skin ulcer, osteomyelitis, or gangrene
* have an allergy to iodocyanine green and inulin
18 Years
75 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Devjit Tripathy, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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DIA4028
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC20170151H
Identifier Type: -
Identifier Source: org_study_id