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
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
2 other identifiers
interventional
171
2 countries
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Oct 2013
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
April 6, 2016
CompletedMarch 3, 2017
March 1, 2017
1.5 years
September 6, 2013
March 8, 2016
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to 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 Outcomes (14)
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Baseline and Day 2
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Baseline, Day 2 and Week 6
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Baseline, Day 2 and Week 6
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Baseline, Day 2 and Week 6
- +9 more secondary outcomes
Study Arms (3)
Canagliflozin 100 mg
EXPERIMENTALEach patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Canagliflozin 300 mg
EXPERIMENTALEach patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Placebo
PLACEBO COMPARATOREach patient will receive matching placebo once daily for 6 weeks.
Interventions
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.
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Gulf Shores, Alabama, United States
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Avondale, Arizona, United States
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Phoenix, Arizona, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Pismo Beach, California, United States
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Rancho Cucamonga, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Denver, Colorado, United States
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Brandon, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Lake Worth, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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West Palm Beach, Florida, United States
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Perry, Georgia, United States
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Rincon, Georgia, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Mandeville, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Auburn, Maine, United States
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Elkridge, Maryland, United States
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Dearborn, Michigan, United States
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Kalamazoo, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Morganville, New Jersey, United States
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Whiting, New Jersey, United States
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Albuquerque, New Mexico, United States
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Raleigh, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Sugar Land, Texas, United States
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Salt Lake City, Utah, United States
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Renton, Washington, United States
Unknown Facility
Carolina, Puerto Rico
Unknown Facility
Ponce Pr, Puerto Rico
Unknown Facility
Trujillo Alto, Puerto Rico
Related Publications (1)
Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.
PMID: 28241822DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 11, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
March 3, 2017
Results First Posted
April 6, 2016
Record last verified: 2017-03