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

January 5, 2015 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

756

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

  • Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belgium
      • Hedersem (Aalst), Belgium
      • Tremelo, Belgium
  • Brazil
      • Belem, Brazil
      • Brasilia, Brazil
      • Fortaleza, Brazil
      • Goiânia, Brazil
      • Marília, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
      • Pointe-Claire, Canada
      • Toronto, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Red Deer, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
    • Quebec
      • Sherbrooke, Quebec, Canada
      • Ville, Laint-Laurent, Quebec, Canada
  • Denmark
      • Aalborg, Denmark
      • Ballerup, Denmark
      • Gentofte, Denmark
      • Vejle, Denmark
      • Vipperoed, Denmark
  • France
      • Bondy Cedex, France
      • Dijon, France
      • Marseille, France
      • Nantes, France
      • Narbonne Cedex, France
      • Paris, France
      • Pessac, France
      • St Etienne, France
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Eisenach, Germany
      • Großheirath, Germany
      • Meißen, Germany
  • India
      • Bangalore, India
      • Coimbatore, India
      • Hyderabad, India
      • Jaipur, India
      • Nagpur, India
      • Nashik, India
      • Pune, India
  • Israel
      • Beer Sheba, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Nazareth, Israel
      • Rishon Lezion, Israel
      • Tel-Aviv, Israel
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Jeonju-Si, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Ipoh, Malaysia
      • Johor Bahru, Malaysia
      • Kelantan, Malaysia
      • Selangor, Malaysia
  • Netherlands
      • Breda, Netherlands
      • Eindhoven, Netherlands
      • Groningen, Netherlands
      • Leiderdorp, Netherlands
      • Rotterdam, Netherlands
      • Velp Gld, Netherlands
      • Zoetermeer, Netherlands
  • New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Rotorua, New Zealand
      • Tauranga, New Zealand
      • Wellington, New Zealand
  • Poland
      • Bialystok, Poland
      • Chrzanow, Poland
      • Gdansk, Poland
      • Kamieniec Zabkowicki, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Sobotka, Poland
      • Sopot, Poland
      • Torun, Poland
      • Wroclaw, Poland
      • Zabrze, Poland
  • Singapore
      • Singapore, Singapore
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Ivano Frankivsk, Ukraine
      • Kharkov, Ukraine
      • Kiev, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Sumy, Ukraine
      • Ternopil, Ukraine
      • Vinnitsa, Ukraine
      • Zaporozhye, Ukraine
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Goodyear, Arizona, United States
      • Mesa, Arizona, United States
    • California
      • Escondido, California, United States
      • Fresno, California, United States
      • Greenbrae, California, United States
      • La Mesa, California, United States
      • Laguna Hills, California, United States
      • Lancaster, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Norwalk, California, United States
      • Pismo Beach, California, United States
      • Roseville, California, United States
      • Spring Valley, California, United States
      • Walnut Creek, California, United States
      • Watsonville, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Northglenn, Colorado, United States
    • Connecticut
      • Milford, Connecticut, United States
    • Florida
      • Bradenton, Florida, United States
      • Cape Coral, Florida, United States
      • Clearwater, Florida, United States
      • Delray Beach, Florida, United States
      • Miami, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Idaho
      • Lewiston, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • O'Fallon, Illinois, United States
      • Springfield, Illinois, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Lexington, Kentucky, United States
      • Madisonville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Mandeville, Louisiana, United States
      • Metairie, Louisiana, United States
      • Sunset, Louisiana, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
    • Michigan
      • Saint Clair Shores, Michigan, United States
      • Southfield, Michigan, United States
    • Nebraska
      • Dakota Dunes, Nebraska, United States
    • New Jersey
      • Toms River, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • West Seneca, New York, United States
    • North Carolina
      • Calabash, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Moerhead City, North Carolina, United States
      • Morganton, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Gallipolis, Ohio, United States
      • Marion, Ohio, United States
      • Mason, Ohio, United States
      • Toledo, Ohio, United States
      • Zanesville, Ohio, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Bensalem, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Perryopolis, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Pottstown, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Johnson City, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Killeen, Texas, United States
      • Richardson, Texas, United States
      • San Antonio, Texas, United States
      • Schertz, Texas, United States
      • Sugar Land, Texas, United States
    • Virginia
      • Burke, Virginia, United States
      • Danville, Virginia, United States
      • Falls Church, Virginia, United States
      • Hampton, Virginia, United States
      • Henrico, Virginia, United States
      • Manassas, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Selah, Washington, United States
      • Tacoma, Washington, 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Drug: Canagliflozin 300 mg
One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Drug: Metformin
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.
Drug: Sulphonylurea
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.
Active Comparator: Sitagliptin 100 mg
Each patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Drug: Metformin
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.
Drug: Sulphonylurea
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.
Drug: Sitagliptin 100 mg
One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea

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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.
Day 1 (Baseline) and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With HbA1c <7% at Week 52
Time Frame: 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.
Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.
Day 1 (Baseline) and Week 52
Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52
Percent Change in Triglycerides From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
Time Frame: Day 1 (Baseline) and 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.
Day 1 (Baseline) and Week 52

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

July 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017185
  • 28431754DIA3015 (Other Identifier: Janssen Research & Development, LLC)

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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