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Diabetes Mellitus, Type 2Phase 3NCT01137812

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

A Phase 3 study testing Sitagliptin 100 mg, Canagliflozin 300 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 184 sites in 17 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Sitagliptin 100 mg, Canagliflozin 300 mg and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
184 sitesin 17 countries
Study dates
Jul 2010to Mar 2012
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
  • Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <300 mg/dL (16.7 mmol/L)

Who cannot join

  • History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • or a severe hypoglycemic episode within 6 months before screening

Trial locations and contacts

184 sites in 17 countries.

184 sites in 17 countries

United States85 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beaver, Pennsylvania

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Bowling Green, Kentucky

  • Study site

    Bradenton, Florida

  • Study site

    Brockton, Massachusetts

  • Study site

    Burke, Virginia

  • Study site

    Calabash, North Carolina

  • Study site

    Cape Coral, Florida

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Dakota Dunes, Nebraska

  • Study site

    Dallas, Texas

  • Study site

    Danville, Virginia

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Escondido, California

  • Study site

    Falls Church, Virginia

  • Study site

    Fort Worth, Texas

  • Study site

    Fresno, California

  • Study site

    Gallipolis, Ohio

  • Study site

    Goodyear, Arizona

  • Study site

    Greenbrae, California

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hampton, Virginia

  • Study site

    Henrico, Virginia

  • Study site

    Houston, Texas

  • Study site

    Johnson City, Tennessee

  • Study site

    Killeen, Texas

  • Study site

    La Mesa, California

  • Study site

    Laguna Hills, California

  • Study site

    Lancaster, California

  • Study site

    Lewiston, Idaho

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Madisonville, Kentucky

  • Study site

    Manassas, Virginia

  • Study site

    Mandeville, Louisiana

  • Study site

    Marion, Ohio

  • Study site

    Mason, Ohio

  • Study site

    Mesa, Arizona

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milford, Connecticut

  • Study site

    Mobile, Alabama

  • Study site

    Moerhead City, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Norfolk, Virginia

  • Study site

    Norristown, Pennsylvania

  • Study site

    Northglenn, Colorado

  • Study site

    Norwalk, California

  • Study site

    O'Fallon, Illinois

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perryopolis, Pennsylvania

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pismo Beach, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Pottstown, Pennsylvania

  • Study site

    Richardson, Texas

  • Study site

    Richmond, Virginia

  • Study site

    Roseville, California

  • Study site

    Saint Clair Shores, Michigan

  • Study site

    San Antonio, Texas

  • Study site

    Schertz, Texas

  • Study site

    Selah, Washington

  • Study site

    Southfield, Michigan

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spring Valley, California

  • Study site

    Springfield, Illinois

  • Study site

    Sugar Land, Texas

  • Study site

    Sunset, Louisiana

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Topeka, Kansas

  • Study site

    Walnut Creek, California

  • Study site

    Watsonville, California

  • Study site

    West Seneca, New York

  • Study site

    Zanesville, Ohio

Other trials in United States

Canada12 sites

  • Study site

    Brampton, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Charlottetown, Prince Edward Island

  • Study site

    Halifax, Nova Scotia

  • Study site

    Oshawa, Ontario

  • Study site

    Pointe-Claire

  • Study site

    Red Deer, Alberta

  • Study site

    Sherbrooke, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Toronto

  • Study site

    Vancouver, British Columbia

  • Study site

    Ville, Laint-Laurent, Quebec

Other trials in Canada

Poland11 sites

  • Study site

    Bialystok

  • Study site

    Chrzanów

  • Study site

    Gdansk

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Sobótka

  • Study site

    Sopot

  • Study site

    Torun

  • Study site

    Wroclaw

  • Study site

    Zabrze

Other trials in Poland

Ukraine10 sites

  • Study site

    Dnipro

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Sumy

  • Study site

    Ternopil

  • Study site

    Vinnitsa

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Brazil9 sites

  • Study site

    Belém

  • Study site

    Brasília

  • Study site

    Fortaleza

  • Study site

    Goiânia

  • Study site

    Marília

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

France8 sites

  • Study site

    Bondy

  • Study site

    Dijon

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Narbonne

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Saint-Etienne

Other trials in France

India7 sites

  • Study site

    Bangalore

  • Study site

    Coimbatore

  • Study site

    Hyderabad

  • Study site

    Jaipur

  • Study site

    Nagpur

  • Study site

    Nashik

  • Study site

    Pune

Other trials in India

Netherlands7 sites

  • Study site

    Breda

  • Study site

    Eindhoven

  • Study site

    Groningen

  • Study site

    Leiderdorp

  • Study site

    Rotterdam

  • Study site

    Velp Gld

  • Study site

    Zoetermeer

Other trials in Netherlands

Israel6 sites

  • Study site

    Beersheba

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Nazareth

  • Study site

    Rishon LeZiyyon

  • Study site

    Tel Aviv

Other trials in Israel

Denmark5 sites

  • Study site

    Aalborg

  • Study site

    Ballerup Municipality

  • Study site

    Gentofte Municipality

  • Study site

    Vejle

  • Study site

    Vipperoed

Other trials in Denmark

Germany5 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Eisenach

  • Study site

    Großheirath

  • Study site

    Meißen

Other trials in Germany

New Zealand5 sites

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Rotorua

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

South Korea5 sites

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Jeonju

  • Study site

    Seongnam

  • Study site

    Seoul

Other trials in South Korea

Malaysia4 sites

  • Study site

    Ipoh

  • Study site

    Johor Bahru

  • Study site

    Kelantan

  • Study site

    Kuala Selangor

Other trials in Malaysia

Austria2 sites

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Belgium2 sites

  • Study site

    Hedersem (Aalst)

  • Study site

    Tremelo

Other trials in Belgium

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Read the detailed description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), multicenter study to determine the efficacy, safety, and tolerability of canagliflozin 300 mg compared to sitagliptin 100 mg (an antihyperglycemic drug) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 720 patients with T2DM who are receiving combination therapy with metformin and sulphonylurea will receive the addition of once-daily treatment with canagliflozin 300 mg or sitagliptin 100 mg capsules for 52 weeks. Patients will participate in the study for approximately 59 to 72 weeks. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self monitored blood glucose (SMBG) measurements. The primary outcome measure in the study is the effect of canagliflozin compared to sitagliptin on hemoglobin A1c (HbA1c) after 52 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single-blind placebo for 2 weeks before randomization. After randomization, patients in the study will take double-blind canagliflozin 300 mg or matching sitagliptin 100 mg for 52 weeks.

Being tested
Sitagliptin 100 mg, Canagliflozin 300 mg, Metformin, Sulphonylurea
Keywords
Canagliflozin, Sitagliptin (Januvia), Metformin, Sulphonylurea, Hemoglobin A1c, Type 2 diabetes mellitus
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.

  • Sitagliptin 100 mgDrug

    One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

  • Canagliflozin 300 mgDrug

    One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

  • MetforminDrug

    Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.

  • SulphonylureaDrug

    Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.

Study groups in NCT01137812
Study groupRoleWhat they receive
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Receives: Drug: Canagliflozin 300 mg; Drug: Metformin; Drug: Sulphonylurea
Sitagliptin 100 mgActive comparatorEach patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Receives: Drug: Sitagliptin 100 mg; Drug: Metformin; Drug: Sulphonylurea

What is being measured

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

  1. Change in HbA1c From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

Secondary outcomes (6)

  1. Percentage of Patients With HbA1c <7% at Week 52

    The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.

    Measured: Week 52

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  3. Percent Change in Body Weight From Baseline to Week 52

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 52

  4. Change in Systolic Blood Pressure (SBP) From Baseline to Week 52

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  5. Percent Change in Triglycerides From Baseline to Week 52

    The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

  6. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

    The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

Timeline

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

  1. First posted4 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01137812
Sponsor's protocol ID
CR017185
Other IDs
28431754DIA3015
Status last verified
Jan 2015
First submitted
3 Jun 2010
Last updated
15 Jan 2015

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

  • Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

    PubMed 27977934

  • Schernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.

    PubMed 27391951

  • Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

    PubMed 26580237

  • Lavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.

    PubMed 26579834

  • Bailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.

    PubMed 25795432

  • Polidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.

    PubMed 24585202

  • Schernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013 Sep;36(9):2508-15. doi: 10.2337/dc12-2491. Epub 2013 Apr 5.

    PubMed 23564919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sitagliptin 100 mg, Canagliflozin 300 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 184 sites in 17 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 2 inclusion and 2 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 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Canada, Poland, Ukraine, Brazil and 12 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 May 2013). 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 in HbA1c From Baseline to Week 52 (time frame: Day 1 (Baseline) and Week 52). 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 NCT01137812, which also lists 8 linked publications.

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 15 Jan 2015.

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