Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: Diabetes Mellitus, Type 2
Hypertension
Canagliflozin
JNJ 28431754
Sodium-Glucose Transporter 2
Blood Glucose
Type 2 Diabetes Mellitus
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
timeFrame: Baseline and Day 2
measure: Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
timeFrame: Baseline, Day 2 and Week 6
measure: Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
timeFrame: Baseline, Day 2 and Week 6
measure: Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
timeFrame: Baseline, Day 2 and Week 6
measure: Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
timeFrame: Baseline, Day 2 and Week 6
measure: Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
timeFrame: Baseline, Day 2 and Week 6
measure: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Body Weight to Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
timeFrame: Baseline, Day 2, Week 3 and 6
measure: Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
timeFrame: Baseline, Day 2, Week 3 and 6
measure: Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
timeFrame: Baseline, Day 2, Week 3 and 6
measure: Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
timeFrame: Baseline, Day 2, Week 3 and 6
measure: 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
timeFrame: Baseline, Day 2, Week 3 and 6
measure: Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
timeFrame: Baseline, Day 2, Week 3 and 6
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Gulf Shores
country: United States
state: Alabama
city: Avondale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Glendale
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Rancho Cucamonga
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Tustin
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Brandon
country: United States
state: Florida
city: Doral
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Perry
country: United States
state: Georgia
city: Rincon
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Topeka
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Mandeville
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Elkridge
country: United States
state: Maryland
city: Dearborn
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Morganville
country: United States
state: New Jersey
city: Whiting
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Raleigh
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Renton
country: United States
state: Washington
city: Carolina
country: Puerto Rico
city: Ponce Pr
country: Puerto Rico
city: Trujillo Alto
country: Puerto Rico
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.