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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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ClinicalTrials.gov Identifier: NCT01939496
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : April 6, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 11, 2013
Results First Submitted Date  ICMJE March 8, 2016
Results First Posted Date  ICMJE April 6, 2016
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
Change in mean 24-hour systolic blood pressure (SBP) by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Baseline and Week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6 [ Time Frame: Baseline and Week 6 ]
    The fasting plasma glucose was evaluated.
  • Change From Baseline in Body Weight to Week 6 [ Time Frame: Baseline and 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 [ 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • Change in mean 24-hour SBP by ABPM [ Time Frame: Baseline and Day 2 ]
  • Change in mean 24-hour diastolic blood pressure (DBP) by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ]
  • Change in mean daytime SBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ]
  • Change in mean daytime DBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ]
  • Change in mean night time SBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ]
  • Change in mean night time DBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Canagliflozin 100 mg
    Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
    Intervention: Drug: Canagliflozin
  • Experimental: Canagliflozin 300 mg
    Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
    Intervention: Drug: Canagliflozin
  • Placebo Comparator: Placebo
    Each patient will receive matching placebo once daily for 6 weeks.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
171
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
189
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939496
Other Study ID Numbers  ICMJE CR102208
28431754DIA4002 ( Other Identifier: Janssen Scientific Affairs, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Scientific Affairs, LLC
Study Sponsor  ICMJE Janssen Scientific Affairs, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
PRS Account Janssen Scientific Affairs, LLC
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP