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

December 1, 2016 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1452

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma De Buenos Aires, Argentina
      • Mar Del Plata, Argentina
      • Rosario, Argentina
  • Bulgaria
      • Dimitrovgrad, Bulgaria
      • Kazanlak, Bulgaria
      • Rousse, Bulgaria
      • Sofia, Bulgaria
  • Canada
      • Quebec, Canada
    • British Columbia
      • Chilliwack, British Columbia, Canada
      • Kelowna, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canada
    • Ontario
      • Mississauga, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Costa Rica
      • San Jose, Costa Rica
      • San Pedro, Costa Rica
  • Denmark
      • Aalborg, Denmark
      • Ballerup, Denmark
      • Vejle, Denmark
      • Vipperoed, Denmark
  • Finland
      • Helsinki, Finland
      • Kokkola, Finland
      • Kuopio, Finland
      • Oulu, Finland
      • Turku, Finland
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Duesseldorf, Germany
      • Hamburg, Germany
      • Mainz, Germany
      • Villingen-Schwenningen, Germany
  • India
      • Bangalore, India
      • Chennai, India
      • Coimbatore, India
      • Hyderabad, India
      • Nagpur, India
      • Pune, India
      • Wardha, India
  • Israel
      • Beer Sheba, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Ramat Gan, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Tel-Aviv, Israel
      • Zefat, Israel
  • Korea, Republic of
      • Daegu, Korea, Republic of
      • Goyang-Si, Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Wonju, Korea, Republic of
      • Wonju-Si, Korea, Republic of
  • Mexico
      • Ciudad De Mexico, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico
  • Norway
      • Alesund, Norway
      • Oslo, Norway
  • Philippines
      • Cebu, Philippines
      • Marikina City, Philippines
      • Pasay, Philippines
      • Quezon City, Philippines
  • Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Kutno 001, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Torun, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
      • Zielona Gora, Poland
  • Puerto Rico
      • Ponce, Puerto Rico
  • Romania
      • Baia Mare, Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Cluj, Romania
      • Galati, Romania
      • Ploiesti, Romania
      • Targu Mures, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saratov, Russian Federation
      • St Petersburg, Russian Federation
  • Slovakia
      • Banska Bystrica, Slovakia
      • Bratislava, Slovakia
      • Lubochna, Slovakia
      • Presov, Slovakia
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Poltava, Ukraine
      • Ternopil, Ukraine
      • Vinnitsa, Ukraine
  • United States
    • Alabama
      • Calera, Alabama, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Mesa, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
    • California
      • Buena Park, California, United States
      • Encinitas, California, United States
      • Fresno, California, United States
      • Lincoln, California, United States
      • Roseville, California, United States
      • San Diego, California, United States
      • Westlake Village, California, United States
    • Florida
      • Chipley, Florida, United States
      • Marianna, Florida, United States
      • Oldsmar, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Perry, Georgia, United States
    • Idaho
      • Nampa, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Vernon Hills, Illinois, United States
    • Indiana
      • Valparaiso, Indiana, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Elkridge, Maryland, United States
    • Michigan
      • Bloomfield Hills, Michigan, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • Ohio
      • Canal Fulton, Ohio, United States
      • Gallipolis, Ohio, United States
      • Mason, Ohio, United States
      • Perrysburg, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
      • Yukon, Oklahoma, United States
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Odessa, Texas, United States
      • Pearland, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Danville, Virginia, United States
    • Washington
      • Olympia, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Glimepiride
Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
Drug: Glimepiride
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.
Other Names:
  • sulfonylurea
Drug: Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
EXPERIMENTAL: Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Drug: Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Drug: Canagliflozin (JNJ-28431754)
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.
EXPERIMENTAL: Canagliflozin 300 mg
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
Drug: Metformin
Metformin will be given orally at the protocol-specified dose for 104 weeks.
Drug: Canagliflozin (JNJ-28431754)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52
Percent Change in Body Weight From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52
Change in HbA1c From Baseline to Week 104
Time Frame: Baseline, 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.
Baseline, Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

August 28, 2009

First Submitted That Met QC Criteria

August 28, 2009

First Posted (ESTIMATE)

August 31, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2017

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016480
  • 28431754DIA3009 (OTHER: Janssen Research & Development, LLC)
  • 2009-009320-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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