Back to resultsEvaluation 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
Primary Purpose
Diabetes Mellitus, Type 2, Hypertension
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Canagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Hypertension, Canagliflozin, JNJ 28431754, Sodium-Glucose Transporter 2, Blood Glucose, Type 2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Canagliflozin 100 mg
Canagliflozin 300 mg
Placebo
Arm Description
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Each patient will receive matching placebo once daily for 6 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and 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.
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to 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.
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to 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.
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to 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.
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to 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.
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
The fasting plasma glucose was evaluated.
Change From Baseline in Body Weight to Week 6
Body weight was evaluated.
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 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.
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 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.
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
The seated heart rate was evaluated.
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
The standing heart rate was evaluated.
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
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
The difference in seated heart rate and standing heart rate was evaluated.
Full Information
NCT ID
NCT01939496
First Posted
September 6, 2013
Last Updated
March 2, 2017
Sponsor
Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01939496
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension
Keywords
Diabetes Mellitus, Type 2, Hypertension, Canagliflozin, JNJ 28431754, Sodium-Glucose Transporter 2, Blood Glucose, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canagliflozin 100 mg
Arm Type
Experimental
Arm Description
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Arm Title
Canagliflozin 300 mg
Arm Type
Experimental
Arm Description
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each patient will receive matching placebo once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Primary Outcome Measure Information:
Title
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
Description
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
Description
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame
Baseline and Day 2
Title
Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Description
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Time Frame
Baseline, Day 2 and Week 6
Title
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Description
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.
Time Frame
Baseline, Day 2 and Week 6
Title
Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Description
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.
Time Frame
Baseline, Day 2 and Week 6
Title
Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
Description
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.
Time Frame
Baseline, Day 2 and Week 6
Title
Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
Description
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.
Time Frame
Baseline, Day 2 and Week 6
Title
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
Description
The fasting plasma glucose was evaluated.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Body Weight to Week 6
Description
Body weight was evaluated.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Description
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.
Time Frame
Baseline, Day 2, Week 3 and 6
Title
Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
Description
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.
Time Frame
Baseline, Day 2, Week 3 and 6
Title
Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Description
The seated heart rate was evaluated.
Time Frame
Baseline, Day 2, Week 3 and 6
Title
Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
Description
The standing heart rate was evaluated.
Time Frame
Baseline, Day 2, Week 3 and 6
Title
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
Description
The difference in seated office blood pressure and standing office blood pressure was evaluated.
Time Frame
Baseline, Day 2, Week 3 and 6
Title
Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
Description
The difference in seated heart rate and standing heart rate was evaluated.
Time Frame
Baseline, Day 2, Week 3 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
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Gulf Shores
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Avondale
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Phoenix
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Fort Lauderdale
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Lake Worth
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Lauderdale Lakes
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Miami
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Orlando
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Perry
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Rincon
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Indianapolis
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Topeka
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Lexington
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Marrero
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Auburn
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Elkridge
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Dearborn
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Kalamazoo
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Jackson
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St. Louis
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Morganville
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Whiting
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Albuquerque
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Raleigh
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Oklahoma City
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Altoona
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Jenkintown
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Nashville
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Dallas
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Houston
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Plano
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Sugar Land
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Salt Lake City
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Renton
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Carolina
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Puerto Rico
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Ponce Pr
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Puerto Rico
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Trujillo Alto
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Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
28241822
Citation
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.
Results Reference
derived
Learn more about this trial
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
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