Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma volume (PV) | Baseline is defined as up to 3 days predose (Week -1) | Baseline to Week 12 of the double-blind treatment period | No |
Primary | 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. | Day 1 to Day 85 | No |
Primary | Number of hypoglycemic events reported | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Change in electrocardiogram (ECG) parameters | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Change in blood pressure measurements | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Number of patients with physical examination findings reported as adverse events | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Week 12 | No |
Primary | Change from baseline in pulse rate (beats/minute) | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Change in chemistry laboratory analytes | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Change from baseline in urinalysis laboratory analytes | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Primary | Change in hematology laboratory analytes | Baseline is defined as up to 3 days predose (Week -1) | Baseline up to Day 98 | No |
Secondary | Change in PV | Baseline is defined as up to 3 days predose (Week -1) | Baseline to Week 1 of the double-blind treatment period | No |
Secondary | Change in body weight | Baseline is defined as up to 3 days predose (Week -1) | Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase | No |
Secondary | Change in 24-hour urine volume | Baseline is defined as up to 3 days predose (Week -1) | Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase | No |
Secondary | Change in 24-hour fractional and total excretion of uric acid | Baseline is defined as up to 3 days predose (Week -1) | Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase | No |
Secondary | Change in urine pH | Baseline is defined as up to 3 days predose (Week -1) | Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase | No |
Secondary | Change in percent Hemoglobin A1c (HbA1c) | Baseline is defined as up to 3 days predose (Week -1) | Baseline to Week 12 | No |
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