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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Scientific Affairs, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01939496
First received: September 6, 2013
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Hypertension
Drug: Canagliflozin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 189
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
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.
Experimental: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
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.
Placebo Comparator: Placebo
Each patient will receive matching placebo once daily for 6 weeks.
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.

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 189 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939496

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 89 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01939496     History of Changes
Other Study ID Numbers: CR102208, 28431754DIA4002
Study First Received: September 6, 2013
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Janssen Scientific Affairs, LLC:
Diabetes Mellitus, Type 2
Hypertension
Canagliflozin
JNJ 28431754
Sodium-Glucose Transporter 2
Blood Glucose
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Antihypertensive Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014