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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01939496
First received: September 6, 2013
Last updated: March 8, 2016
Last verified: March 2016

September 6, 2013
March 8, 2016
October 2013
April 2015   (final data collection date for primary outcome measure)
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
Change in mean 24-hour systolic blood pressure (SBP) by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01939496 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2 [ Time Frame: Baseline and Day 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The fasting plasma glucose was evaluated.
  • Change From Baseline in Body Weight to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The difference in seated heart rate and standing heart rate was evaluated.
  • Change in mean 24-hour SBP by ABPM [ Time Frame: Baseline and Day 2 ] [ Designated as safety issue: No ]
  • Change in mean 24-hour diastolic blood pressure (DBP) by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ] [ Designated as safety issue: No ]
  • Change in mean daytime SBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ] [ Designated as safety issue: No ]
  • Change in mean daytime DBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ] [ Designated as safety issue: No ]
  • Change in mean night time SBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ] [ Designated as safety issue: No ]
  • Change in mean night time DBP by ABPM [ Time Frame: Baseline, Day 2, and Week 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Hypertension
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01939496
CR102208, 28431754DIA4002
No
Not Provided
Not Provided
Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
Not Provided
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Janssen Scientific Affairs, LLC
March 2016

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