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Diabetes Mellitus, Type 2Phase 4NCT01939496

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 Phase 4 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Hypertension, run by Janssen Scientific Affairs, LLC at 57 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2, Hypertension
What is being tested?
Canagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
57 sitesin 2 countries
Study dates
Oct 2013to Apr 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

57 sites in 2 countries.

57 sites in 2 countries

United States54 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Altoona, Pennsylvania

  • Study site

    Auburn, Maine

  • Study site

    Austin, Texas

  • Study site

    Avondale, Arizona

  • Study site

    Birmingham, Alabama

  • Study site

    Brandon, Florida

  • Study site

    Dallas, Texas

  • Study site

    Dearborn, Michigan

  • Study site

    Denver, Colorado

  • Study site

    Doral, Florida

  • Study site

    Elkridge, Maryland

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Glendale, California

  • Study site

    Gulf Shores, Alabama

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Mississippi

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Kalamazoo, Michigan

  • Study site

    Lake Worth, Florida

  • Study site

    Lauderdale Lakes, Florida

  • Study site

    Lexington, Kentucky

  • Study site

    Los Angeles, California

  • Study site

    Mandeville, Louisiana

  • Study site

    Marrero, Louisiana

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Miami Lakes, Florida

  • Study site

    Morganville, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    Newport Beach, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perry, Georgia

  • Study site

    Phoenix, Arizona

  • Study site

    Pismo Beach, California

  • Study site

    Plano, Texas

  • Study site

    Port Orange, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Rancho Cucamonga, California

  • Study site

    Renton, Washington

  • Study site

    Rincon, Georgia

  • Study site

    Roseville, California

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    Spring Valley, California

  • Study site

    St Louis, Missouri

  • Study site

    Sugar Land, Texas

  • Study site

    Topeka, Kansas

  • Study site

    Tustin, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Whiting, New Jersey

Other trials in United States

Puerto Rico3 sites

  • Study site

    Carolina

  • Study site

    Ponce Pr

  • Study site

    Trujillo Alto

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Canagliflozin, Placebo
Keywords
Diabetes Mellitus, Type 2, Hypertension, Canagliflozin, JNJ 28431754, Sodium-Glucose Transporter 2, Blood Glucose, Type 2 Diabetes Mellitus
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanagliflozinDrug

    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.

  • PlaceboDrug

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

Study groups in NCT01939496
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 6 weeks.
Receives: Drug: Canagliflozin
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 6 weeks.
Receives: Drug: Canagliflozin
PlaceboPlacebo comparatorEach patient will receive matching placebo once daily for 6 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6

    The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.

    Measured: Baseline and Week 6

Secondary outcomes (14)

  1. Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2

    The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.

    Measured: Baseline and Day 2

  2. Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6

    The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.

    Measured: Baseline, Day 2 and Week 6

  3. Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to 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.

    Measured: Baseline, Day 2 and Week 6

  4. Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to 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.

    Measured: Baseline, Day 2 and Week 6

  5. Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to 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.

    Measured: Baseline, Day 2 and Week 6

  6. Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to 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.

    Measured: Baseline, Day 2 and Week 6

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

    The fasting plasma glucose was evaluated.

    Measured: Baseline and Week 6

  8. Change From Baseline in Body Weight to Week 6

    Body weight was evaluated.

    Measured: Baseline and Week 6

  9. Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 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.

    Measured: Baseline, Day 2, Week 3 and 6

  10. Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 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.

    Measured: Baseline, Day 2, Week 3 and 6

  11. Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6

    The seated heart rate was evaluated.

    Measured: Baseline, Day 2, Week 3 and 6

  12. Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6

    The standing heart rate was evaluated.

    Measured: Baseline, Day 2, Week 3 and 6

  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

    The difference in seated office blood pressure and standing office blood pressure was evaluated.

    Measured: Baseline, Day 2, Week 3 and 6

  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

    The difference in seated heart rate and standing heart rate was evaluated.

    Measured: Baseline, Day 2, Week 3 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939496
Sponsor's protocol ID
CR102208
Other IDs
28431754DIA4002
Status last verified
Mar 2017
First submitted
6 Sep 2013
Last updated
3 Mar 2017
Data monitoring committee
No

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.

    PubMed 28241822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Hypertension, run by Janssen Scientific Affairs, LLC at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939496, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.

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