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Diabetes Mellitus, Type 2Phase 3NCT01106625

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

A Phase 3 study testing Canagliflozin, Metformin and Sulphonylruea in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 76 sites in 12 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 2 different doses of canagliflozin compared with placebo 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 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Canagliflozin, Metformin and Sulphonylruea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
469 participants
Where
76 sitesin 12 countries
Study dates
May 2010to Apr 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 to 80 years
  • 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%
  • Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 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

76 sites in 12 countries.

76 sites in 12 countries

United States37 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Augusta, Georgia

  • Study site

    Bryan, Texas

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Dallas, Texas

  • Study site

    DeSoto, Texas

  • Study site

    Fair Oaks, California

  • Study site

    Greenville, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Harleysville, Pennsylvania

  • Study site

    Huntsville, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Levittown, Pennsylvania

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Alaska

  • Study site

    Medford, Oregon

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    Ocala, Florida

  • Study site

    Olive Branch, Mississippi

  • Study site

    Phoenix, Arizona

  • Study site

    Reisterstown, Maryland

  • Study site

    Roseville, California

  • Study site

    Roswell, Georgia

  • Study site

    Salt Lake City, Utah

  • Study site

    Sellersville, Pennsylvania

  • Study site

    South Burlington, Vermont

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tulsa, Oklahoma

  • Study site

    Waterbury, Connecticut

  • Study site

    Wenatchee, Washington

  • Study site

    Wes Hills, California

  • Study site

    West Palm Beach, Florida

  • Study site

    Westfield, New York

Other trials in United States

Australia5 sites

  • Study site

    Freemantle

  • Study site

    Heidelberg Heights

  • Study site

    Meadowbrook

  • Study site

    Nedlands

  • Study site

    Wollongong

Other trials in Australia

France5 sites

  • Study site

    Corbeil-Essonnes

  • Study site

    La Rochelle

  • Study site

    Le Creusot

  • Study site

    Poitiers

  • Study site

    Vénissieux

Other trials in France

Spain5 sites

  • Study site

    Alicante

  • Study site

    Almería

  • Study site

    Málaga

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Belgium4 sites

  • Study site

    Aalst

  • Study site

    Bonheiden

  • Study site

    Edegem

  • Study site

    Leuven

Other trials in Belgium

Hungary4 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Győr

  • Study site

    Zalaegerszeg

Other trials in Hungary

Israel4 sites

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Jerusalem

  • Study site

    Tel Aviv

Other trials in Israel

United Kingdom4 sites

  • Study site

    Belfast

  • Study site

    Bolton

  • Study site

    Liverpool

  • Study site

    Manchester

Other trials in United Kingdom

Russia3 sites

  • Study site

    Arkhangelsk

  • Study site

    Saint Petersburg

  • Study site

    Samara

Other trials in Russia

Mexico2 sites

  • Study site

    Guadalajara

  • Study site

    Monterrey

Other trials in Mexico

Puerto Rico2 sites

  • Study site

    Carolina

  • Study site

    Trujillo Alto

Other trials in Puerto Rico

Guatemala1 site

  • Study site

    Guatemala City

Other trials in Guatemala

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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 Sulphonylurea Therapy

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo 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), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 450 patients with T2DM who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 52 weeks (includes 26 weeks of double-blind treatment followed by a 26-week extension period). In addition, all patients will take protocol-specified stable doses of metformin and sulphonylurea for the duration of the study. Patients will participate in the study for approximately 59 to 72 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with insulin (rescue therapy) consistent with local prescribing information. 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 (SMGB) measurements. The primary outcome measure in the study is to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) or matching placebo for 52 weeks.

Being tested
Canagliflozin, Placebo, Metformin, Sulphonylruea
Keywords
Canagliflozin, Placebo, 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.

  • CanagliflozinDrug

    One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

  • PlaceboDrug

    One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

  • MetforminDrug

    The patient's stable dose of background metformin therapy should be continued throughout the study.

  • SulphonylrueaDrug

    The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.

Study groups in NCT01106625
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Receives: Drug: Canagliflozin; Drug: Metformin; Drug: Sulphonylruea
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; Drug: Metformin; Drug: Sulphonylruea
PlaceboPlacebo comparatorEach patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
Receives: Drug: Placebo; Drug: Metformin; Drug: Sulphonylruea

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 26

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

Secondary outcomes (6)

  1. Percentage of Patients With HbA1c <7% at Week 26

    The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.

    Measured: Week 26

  2. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  3. Percent Change in Body Weight From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

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

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.

    Measured: Day 1 (Baseline) and Week 26

  5. Percent Change in Triglycerides From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (Baseline) and Week 26

  6. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

    The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.

    Measured: Day 1 (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 posted20 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2011
  4. Study completionApr 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
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106625
Sponsor's protocol ID
CR017005
Other IDs
28431754DIA3002
Status last verified
Jun 2013
First submitted
1 Apr 2010
Last updated
20 Jun 2013
Data monitoring committee
Yes

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

  • Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

    PubMed 28327140

  • Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

    PubMed 28241822

  • Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

    PubMed 28197834

  • 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

  • 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

  • Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

    PubMed 26373629

  • Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

    PubMed 26121561

  • Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

    PubMed 25813214

  • Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

    PubMed 25329038

  • Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

    PubMed 24918789

  • Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

    PubMed 24786834

  • Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

    PubMed 24742013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin, Metformin and Sulphonylruea in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 76 sites in 12 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 1 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Australia, France, Spain, Belgium and 7 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. 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 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 29 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 26 (time frame: Day 1 (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 NCT01106625, which also lists 17 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 20 Jun 2013.

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