Effects of Canagliflozin on Intravascular Volume and Hemodynamics

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Type2 Diabetes Mellitus, Cardiovascular Diseases

In brief

RESEARCH HYPOTHESIS * 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.

Key facts

Study ID

NCT03190798

Run by

The University of Texas Health Science Center at San Antonio

People needed

0

Starts

2017-09-01

Expected to finish

2018-08-01

Last updated by the study team

2017-10-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• on stable doses (more than 3 months) of antihyperglycemic agents (except for an SGLT2 inhibitor and insulin)
• 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

You may not qualify if…

• T1DM
• 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

Where it is running

• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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