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Completed

NCT Number: NCT01939496

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Carolina, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Canagliflozin

Drug

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

Drug

One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  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.

  7. Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6

    Time frame: Baseline and Week 6

    The fasting plasma glucose was evaluated.

  8. Change From Baseline in Body Weight to Week 6

    Time frame: Baseline and Week 6

    Body weight was evaluated.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Janssen Scientific Affairs, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2013
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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