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Diabetes Mellitus, Type 2Phase 4NCT02025907

A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

A Phase 4 study testing Canagliflozin, 100 mg and Canagliflozin, 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 57 sites in 5 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 assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin, 100 mg and Canagliflozin, 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
57 sitesin 5 countries
Study dates
Feb 2014to Sep 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

  • Must have a diagnosis of type 2 diabetes mellitus
  • Must have a screening HbA1c of >=7.5% to <=10.5%
  • Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Who cannot join

  • History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
  • A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
  • eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
  • Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
  • Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Trial locations and contacts

57 sites in 5 countries.

57 sites in 5 countries

United States30 sites

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Bountiful, Utah

  • Study site

    Cooper City, Florida

  • Study site

    Denver, Colorado

  • Study site

    Jackson, Mississippi

  • Study site

    Little Rock, Arkansas

  • Study site

    Littleton, Colorado

  • Study site

    Marrero, Louisiana

  • Study site

    Metairie, Louisiana

  • Study site

    Metarie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Montgomery, Alabama

  • Study site

    Nashua, New Hampshire

  • Study site

    North Miami Beach, Florida

  • Study site

    Northridge, California

  • Study site

    Norwalk, California

  • Study site

    Perry, Georgia

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Rancho Cucamonga, California

  • Study site

    Rockville, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Ramon, California

  • Study site

    Shawnee Mission, Kansas

  • Study site

    St Louis, Missouri

  • Study site

    Sugarland, Texas

Other trials in United States

Australia10 sites

  • Study site

    Coffs Harbour

  • Study site

    Freemantle

  • Study site

    Geelong

  • Study site

    Heidelberg

  • Study site

    Herston

  • Study site

    Melbourne

  • Study site

    Merewether

  • Study site

    Sherwood

  • Study site

    Sydney

  • Study site

    Wollongong

Other trials in Australia

France7 sites

  • Study site

    La Rochelle Cedex 1 Poitou-Cha

  • Study site

    La Tronche

  • Study site

    Nancy

  • Study site

    Narbonne

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Vénissieux

Other trials in France

Germany7 sites

  • Study site

    Freiburg im Breisgau

  • Study site

    Fulda

  • Study site

    Hamburg

  • Study site

    Münster

  • Study site

    Neuwied

  • Study site

    Pirna

  • Study site

    Speyer

Other trials in Germany

Canada3 sites

  • Study site

    Brampton, Ontario

  • Study site

    Hawkesbury, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Read the detailed description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Being tested
Canagliflozin, 100 mg, Canagliflozin, 300 mg, Placebo
Keywords
Diabetes Mellitus, Type 2, Canagliflozin, Hemoglobin A1c, Metformin, Sitagliptin, T2DM, JNJ-28431754
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Canagliflozin, 100 mgDrug

    One 100 mg capsule taken orally (by mouth) once daily.

  • Canagliflozin, 300 mgDrug

    One 300 mg capsule taken orally (by mouth) once daily.

  • PlaceboDrug

    One placebo capsule taken orally (by mouth) once daily.

Study groups in NCT02025907
Study groupRoleWhat they receive
Canagliflozin (JNJ-28431754)ExperimentalEach participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
Receives: Drug: Canagliflozin, 100 mg; Drug: Canagliflozin, 300 mg
PlaceboPlacebo comparatorEach participant will receive placebo (inactive medication) once daily for 28 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 Glycosylated Hemoglobin (HbA1c) at Week 26

    Measured: Baseline and Week 26

Secondary outcomes (4)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

    Measured: Baseline and Week 26

  2. Percent Change From Baseline in Body Weight at Week 26

    Measured: Baseline and Week 26

  3. Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26

    Measured: Week 26

  4. Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

    Measured: Baseline and Week 26

Timeline

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

  1. First posted1 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionSep 2015
  4. Study completionSep 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
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02025907
Sponsor's protocol ID
CR103477
Other IDs
2013-004819-40, 28431754DIA4004
Status last verified
Oct 2016
First submitted
30 Dec 2013
Last updated
31 Oct 2016
Data monitoring committee
No

Publications

  • Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

    PubMed 29313267

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Canagliflozin, 100 mg and Canagliflozin, 300 mg in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 57 sites in 5 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 3 inclusion and 5 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 31 Oct 2016. 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, Australia, France, Germany, Canada. 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 2 Sep 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 Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline and Week 26). 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 NCT02025907, 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 31 Oct 2016.

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