The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.
This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks)
Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
Unnamed facility
Neuss, Germany
Change in plasma volume (PV)
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to Week 12 of the double-blind treatment period
Number of patients who experience at least 1 occurrence of a treatment-related adverse event
Treatment-related adverse events are adverse events with onset during the treatment phase.
Time frame: Day 1 to Day 85
Number of hypoglycemic events reported
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Change in electrocardiogram (ECG) parameters
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Change in blood pressure measurements
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Number of patients with physical examination findings reported as adverse events
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Week 12
Change from baseline in pulse rate (beats/minute)
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Change in chemistry laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
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Change from baseline in urinalysis laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Change in hematology laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline up to Day 98
Change in PV
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to Week 1 of the double-blind treatment period
Change in body weight
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour urine volume
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour fractional and total excretion of uric acid
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in urine pH
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in percent Hemoglobin A1c (HbA1c)
Baseline is defined as up to 3 days predose (Week -1)
Time frame: Baseline to Week 12