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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01483781
Other study ID # CR100685
Secondary ID 28431754DIA10472
Status Completed
Phase Phase 1
First received November 30, 2011
Last updated August 19, 2014
Start date December 2011
Est. completion date August 2012

Study information

Verified date August 2014
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority Germany: Bundesinstitute fur Arzneimittel and Medizinproduckte (Federal Institute for Medicinal products and Devices)
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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)
Placebo
Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

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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