Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

March 2, 2017 updated by: Janssen Scientific Affairs, LLC

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction With Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Hypertension and Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 4

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

  • Puerto Rico
      • Carolina, Puerto Rico
      • Ponce Pr, Puerto Rico
      • Trujillo Alto, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Gulf Shores, Alabama, United States
    • Arizona
      • Avondale, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • Glendale, California, United States
      • Los Angeles, California, United States
      • Newport Beach, California, United States
      • Pismo Beach, California, United States
      • Rancho Cucamonga, California, United States
      • Roseville, California, United States
      • Sacramento, California, United States
      • Spring Valley, California, United States
      • Tustin, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Brandon, Florida, United States
      • Doral, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Lake Worth, Florida, United States
      • Lauderdale Lakes, Florida, United States
      • Miami, Florida, United States
      • Miami Lakes, Florida, United States
      • Orlando, Florida, United States
      • Pembroke Pines, Florida, United States
      • Port Orange, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Perry, Georgia, United States
      • Rincon, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • Mandeville, Louisiana, United States
      • Marrero, Louisiana, United States
      • Metairie, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
    • Maryland
      • Elkridge, Maryland, United States
    • Michigan
      • Dearborn, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Morganville, New Jersey, United States
      • Whiting, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • North Carolina
      • Raleigh, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • Sugar Land, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Renton, Washington, United States

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with a diagnosis of type 2 diabetes mellitus
  • patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
  • patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
  • patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion Criteria:

  • a history of diabetic ketoacidosis
  • type 1 diabetes mellitus (T1DM)
  • pancreas or beta-cell transplantation
  • fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
  • body mass index <30 kg/m2
  • has ongoing, inadequately controlled thyroid disorder
  • has a history of cardio-renal disease that required treatment with immunosuppressive therapy.

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
Experimental: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Experimental: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Drug: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Placebo Comparator: Placebo
Each patient will receive matching placebo once daily for 6 weeks.
Drug: Placebo
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Time Frame: Baseline and Week 6
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline and Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Time Frame: Baseline and Day 2
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline and Day 2
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Time Frame: Baseline, Day 2 and Week 6
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Time Frame: Baseline, Day 2 and Week 6
The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Time Frame: Baseline, Day 2 and Week 6
The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Time Frame: Baseline, Day 2 and Week 6
The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Time Frame: Baseline, Day 2 and Week 6
The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Baseline, Day 2 and Week 6
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Time Frame: Baseline and Week 6
The fasting plasma glucose was evaluated.
Baseline and Week 6
Change From Baseline in Body Weight to Week 6
Time Frame: Baseline and Week 6
Body weight was evaluated.
Baseline and Week 6
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The seated heart rate was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The standing heart rate was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Baseline, Day 2, Week 3 and 6
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Time Frame: Baseline, Day 2, Week 3 and 6
The difference in seated heart rate and standing heart rate was evaluated.
Baseline, Day 2, Week 3 and 6

Collaborators and Investigators

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

Sponsor

Janssen Scientific Affairs, 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.

General Publications

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

October 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR102208
  • 28431754DIA4002 (Other Identifier: Janssen Scientific Affairs, LLC)

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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