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Diabetes Mellitus, Type 2Phase 3NCT00968812

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

A Phase 3 study testing Glimepiride, Canagliflozin (JNJ-28431754) and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 138 sites in 20 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 demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Glimepiride, Canagliflozin (JNJ-28431754) and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,452 participants
Where
138 sitesin 20 countries
Study dates
Sep 2009to Jan 2013
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of type 2 diabetes
  • Body mass index (BMI) >=22 to <=45 kg/m2, at screening
  • Patients must be taking a stable dosage of metformin as monotherapy at screening
  • Patients must have a HbA1c between >=7% and <=9.5% at Week 2
  • Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2

Who cannot join

  • Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
  • History of diabetic ketoacidosis or type 1 diabetes mellitus
  • History of pancreas or beta-cell transplantation
  • History of active proliferative diabetic retinopathy
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
  • Taken thiazolidinedione therapy in the past 16 weeks before screening

Trial locations and contacts

138 sites in 20 countries.

138 sites in 20 countries

United States43 sites

  • Study site

    Augusta, Georgia

  • Study site

    Bloomfield Hills, Michigan

  • Study site

    Buena Park, California

  • Study site

    Calera, Alabama

  • Study site

    Canal Fulton, Ohio

  • Study site

    Chicago, Illinois

  • Study site

    Chipley, Florida

  • Study site

    Danville, Virginia

  • Study site

    Elkridge, Maryland

  • Study site

    Encinitas, California

  • Study site

    Fleetwood, Pennsylvania

  • Study site

    Fresno, California

  • Study site

    Gallipolis, Ohio

  • Study site

    Gilbert, Arizona

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Jonesboro, Arkansas

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, California

  • Study site

    Marianna, Florida

  • Study site

    Mason, Ohio

  • Study site

    Mesa, Arizona

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nampa, Idaho

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    Odessa, Texas

  • Study site

    Oldsmar, Florida

  • Study site

    Olympia, Washington

  • Study site

    Orlando, Florida

  • Study site

    Pearland, Texas

  • Study site

    Perry, Georgia

  • Study site

    Perrysburg, Ohio

  • Study site

    Roseville, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Valparaiso, Indiana

  • Study site

    Vernon Hills, Illinois

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    Westlake Village, California

  • Study site

    Yukon, Oklahoma

Other trials in United States

Poland9 sites

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Kutno

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

  • Study site

    Zielona Góra

Other trials in Poland

Canada8 sites

  • Study site

    Chilliwack, British Columbia

  • Study site

    Kelowna, British Columbia

  • Study site

    Mississauga, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Israel8 sites

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Ramat Gan

  • Study site

    Rehovot

  • Study site

    Safed

  • Study site

    Tel Aviv

Other trials in Israel

India7 sites

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Coimbatore

  • Study site

    Hyderabad

  • Study site

    Nagpur

  • Study site

    Pune

  • Study site

    Wardha

Other trials in India

Romania7 sites

  • Study site

    Baia Mare

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Galati

  • Study site

    Ploieşti

  • Study site

    Târgu Mureş

Other trials in Romania

South Korea7 sites

  • Study site

    Daegu

  • Study site

    Goyang-si

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Wŏnju

Other trials in South Korea

Germany6 sites

  • Study site

    Berlin

  • Study site

    Dresden

  • Study site

    Düsseldorf

  • Study site

    Hamburg

  • Study site

    Mainz

  • Study site

    Villingen-Schwenningen

Other trials in Germany

Ukraine6 sites

  • Study site

    Dnipro

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Poltava

  • Study site

    Ternopil

  • Study site

    Vinnitsa

Other trials in Ukraine

Finland5 sites

  • Study site

    Helsinki

  • Study site

    Kokkola

  • Study site

    Kuopio

  • Study site

    Oulu

  • Study site

    Turku

Other trials in Finland

Russia5 sites

  • Study site

    Arkhangelsk

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

Other trials in Russia

Bulgaria4 sites

  • Study site

    Dimitrovgrad

  • Study site

    Kazanlak

  • Study site

    Rousse

  • Study site

    Sofia

Other trials in Bulgaria

Denmark4 sites

  • Study site

    Aalborg

  • Study site

    Ballerup Municipality

  • Study site

    Vejle

  • Study site

    Vipperoed

Other trials in Denmark

Philippines4 sites

  • Study site

    Cebu

  • Study site

    Marikina City

  • Study site

    Pasay

  • Study site

    Quezon City

Other trials in Philippines

Slovakia4 sites

  • Study site

    Banská Bystrica

  • Study site

    Bratislava

  • Study site

    Ľubochňa

  • Study site

    Prešov

Other trials in Slovakia

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Mar del Plata

  • Study site

    Rosario

Other trials in Argentina

Mexico3 sites

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Monterrey

Other trials in Mexico

Costa Rica2 sites

  • Study site

    San José

  • Study site

    San Pedro

Other trials in Costa Rica

Norway2 sites

  • Study site

    Ålesund

  • Study site

    Oslo

Other trials in Norway

Puerto Rico1 site

  • Study site

    Ponce

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.

Being tested
Glimepiride, Canagliflozin (JNJ-28431754), Metformin
Keywords
Diabetes, Metformin, Glimepiride, Hemoglobin A1c, Type 2 diabetes mellitus, Canagliflozin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • GlimepirideDrug

    Also called sulfonylurea

    Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.

  • Canagliflozin (JNJ-28431754)Drug

    Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.

  • MetforminDrug

    Metformin will be given orally at the protocol-specified dose for 104 weeks.

Study groups in NCT00968812
Study groupRoleWhat they receive
GlimepirideActive comparatorEach patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
Receives: Drug: Glimepiride; Drug: Metformin
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Metformin
Canagliflozin 300 mgExperimentalEach volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Receives: Drug: Canagliflozin (JNJ-28431754); Drug: Metformin

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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 52

Secondary outcomes (3)

  1. Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

    The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.

    Measured: Day 1 (Baseline) and Week 52

  2. 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 52

  3. Change in HbA1c From Baseline to Week 104

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

    Measured: Baseline, Week 104

Timeline

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

  1. First posted31 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2011
  4. Study completionJan 2013

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00968812
Sponsor's protocol ID
CR016480
Other IDs
28431754DIA3009, 2009-009320-36, 2009
Status last verified
Dec 2016
First submitted
28 Aug 2009
Last updated
30 Jan 2017
Data monitoring committee
Yes

Publications

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • Heerspink HJL, Perco P, Mulder S, Leierer J, Hansen MK, Heinzel A, Mayer G. Canagliflozin reduces inflammation and fibrosis biomarkers: a potential mechanism of action for beneficial effects of SGLT2 inhibitors in diabetic kidney disease. Diabetologia. 2019 Jul;62(7):1154-1166. doi: 10.1007/s00125-019-4859-4. Epub 2019 Apr 17.

    PubMed 31001673

  • Garvey WT, Van Gaal L, Leiter LA, Vijapurkar U, List J, Cuddihy R, Ren J, Davies MJ. Effects of canagliflozin versus glimepiride on adipokines and inflammatory biomarkers in type 2 diabetes. Metabolism. 2018 Aug;85:32-37. doi: 10.1016/j.metabol.2018.02.002. Epub 2018 Feb 13.

    PubMed 29452178

  • 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

  • John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

    PubMed 27600862

  • Patel CA, Bailey RA, Vijapurkar U, Meininger G, Blonde L. A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures. BMC Health Serv Res. 2016 Aug 5;16(a):356. doi: 10.1186/s12913-016-1607-z.

    PubMed 27495291

  • Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

    PubMed 27002421

  • Leiter LA, Langslet G, Vijapurkar U, Davies MJ, Canovatchel W. Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin. Diabetes Ther. 2016 Jun;7(2):269-78. doi: 10.1007/s13300-016-0163-1. Epub 2016 Mar 16.

    PubMed 26984361

  • 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

  • Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9.

    PubMed 25205142

  • Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

    PubMed 24517339

  • Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12.

    PubMed 23850055

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glimepiride, Canagliflozin (JNJ-28431754) and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 138 sites in 20 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 5 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Poland, Canada, Israel, India and 15 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 4 Jun 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 NCT00968812, which also lists 13 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 30 Jan 2017.

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