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

August 19, 2014 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
Experimental: Canagliflozin
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma volume (PV)
Time Frame: Baseline to Week 12 of the double-blind treatment period
Baseline is defined as up to 3 days predose (Week -1)
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
Time Frame: Day 1 to Day 85
Treatment-related adverse events are adverse events with onset during the treatment phase.
Day 1 to Day 85
Number of hypoglycemic events reported
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Change in electrocardiogram (ECG) parameters
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Change in blood pressure measurements
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Number of patients with physical examination findings reported as adverse events
Time Frame: Baseline up to Week 12
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Week 12
Change from baseline in pulse rate (beats/minute)
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Change in chemistry laboratory analytes
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Change from baseline in urinalysis laboratory analytes
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98
Change in hematology laboratory analytes
Time Frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Baseline up to Day 98

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PV
Time Frame: Baseline to Week 1 of the double-blind treatment period
Baseline is defined as up to 3 days predose (Week -1)
Baseline to Week 1 of the double-blind treatment period
Change in body weight
Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Baseline is defined as up to 3 days predose (Week -1)
Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour urine volume
Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Baseline is defined as up to 3 days predose (Week -1)
Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
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
Baseline is defined as up to 3 days predose (Week -1)
Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in urine pH
Time Frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Baseline is defined as up to 3 days predose (Week -1)
Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in percent Hemoglobin A1c (HbA1c)
Time Frame: Baseline to Week 12
Baseline is defined as up to 3 days predose (Week -1)
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC L.L.C. Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100685
  • 28431754DIA1047 (Other Identifier: Janssen Research & Development, LLC)
  • 2011-004117-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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