A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01483781
First received: November 30, 2011
Last updated: March 1, 2013
Last verified: March 2013

November 30, 2011
March 1, 2013
December 2011
August 2012   (final data collection date for primary outcome measure)
  • Change in plasma volume (PV) [ Time Frame: Baseline to Week 12 of the double-blind treatment period ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Number of patients who experience at least 1 occurrence of a treatment-related adverse event [ Time Frame: Day 1 to Day 85 ] [ Designated as safety issue: No ]
    Treatment-related adverse events are adverse events with onset during the treatment phase.
  • Number of hypoglycemic events reported [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in electrocardiogram (ECG) parameters [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in blood pressure measurements [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Number of patients with physical examination findings reported as adverse events [ Time Frame: Baseline up to Week 12 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change from baseline in pulse rate (beats/minute) [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in chemistry laboratory analytes [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change from baseline in urinalysis laboratory analytes [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in hematology laboratory analytes [ Time Frame: Baseline up to Day 98 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
Same as current
Complete list of historical versions of study NCT01483781 on ClinicalTrials.gov Archive Site
  • Change in PV [ Time Frame: Baseline to Week 1 of the double-blind treatment period ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in body weight [ Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in 24-hour urine volume [ Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in 24-hour fractional and total excretion of uric acid [ Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in urine pH [ Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
  • Change in percent Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    Baseline is defined as up to 3 days predose (Week -1)
Same as current
Not Provided
Not Provided
 
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus
A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Plasma Volume
  • Drug: Canagliflozin
    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)
  • Drug: Placebo
    Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
  • Experimental: Canagliflozin
    Intervention: Drug: Canagliflozin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of >=7.0% and <=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening

Exclusion Criteria:

-History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening

Both
25 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01483781
CR100685, 28431754DIA1047, 2011-004117-17
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC L.L.C. Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP