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Diabetes Mellitus, Type 2Phase 3NCT01081834

The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

A Phase 3 study testing Canagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 78 sites in 18 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, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise. 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 and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
678 participants
Where
78 sitesin 18 countries
Study dates
Mar 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 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
  • Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
  • Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)

Who cannot join

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

Trial locations and contacts

78 sites in 18 countries.

78 sites in 18 countries

United States24 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Colorado Springs, Colorado

  • Study site

    Concord, California

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Evansville, Indiana

  • Study site

    Greenbrae, California

  • Study site

    Houston, Texas

  • Study site

    Los Angeles, California

  • Study site

    Meridian, New Jersey

  • Study site

    Metairie, Louisiana

  • Study site

    Mooresville, North Carolina

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Northglenn, Colorado

  • Study site

    Perryopolis, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    San Antonio, Texas

  • Study site

    Spring Valley, California

  • Study site

    Springfield, Illinois

  • Study site

    Taylors, South Carolina

  • Study site

    West Seneca, New York

Other trials in United States

Lithuania5 sites

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Šiauliai

  • Study site

    Vilnius

  • Study site

    Vilnius Lt

Other trials in Lithuania

Mexico5 sites

  • Study site

    Aguascalientes

  • Study site

    Guadalajara

  • Study site

    Mexico City

  • Study site

    Monterrey

  • Study site

    Zapopan

Other trials in Mexico

South Korea5 sites

  • Study site

    Busan

  • Study site

    Goyang-si

  • Study site

    Jeonju

  • Study site

    Seoul

  • Study site

    Wŏnju

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Philippines4 sites

  • Study site

    Makati

  • Study site

    Manila

  • Study site

    Marikina City

  • Study site

    Pasay

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Romania4 sites

  • Study site

    Baia Mare

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Târgu Mureş

Other trials in Romania

Spain4 sites

  • Study site

    Alcalá de Henares

  • Study site

    Elche

  • Study site

    Girona

  • Study site

    Pozuelo de Alarcón

Other trials in Spain

Sweden4 sites

  • Study site

    Gothenburg

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Skene

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Austria3 sites

  • Study site

    Horn

  • Study site

    Salzburg

  • Study site

    Vienna

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Estonia3 sites

  • Study site

    Pärnu

  • Study site

    Tartu

  • Study site

    Viljandi

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India3 sites

  • Study site

    Bangalore

  • Study site

    Hyderabad

  • Study site

    Nagpur

Other trials in India

Poland3 sites

  • Study site

    Katowice

  • Study site

    Torun

  • Study site

    Warsaw

Other trials in Poland

Puerto Rico3 sites

  • Study site

    Fajardo

  • Study site

    Ponce

  • Study site

    San Juan

Other trials in Puerto Rico

Colombia2 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

Other trials in Colombia

Malaysia2 sites

  • Study site

    Kelantan

  • Study site

    Kuala Lumpur

Other trials in Malaysia

South Africa2 sites

  • Study site

    Halfway

  • Study site

    Pretoria

Other trials in South Africa

Guatemala1 site

  • Study site

    Guatemala City

Other trials in Guatemala

Iceland1 site

  • Study site

    Reykjavik

Other trials in Iceland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

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), parallel-group, 3 arm (patients will be assigned to 1 of 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 diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. 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 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy.

Being tested
Canagliflozin, Placebo, Sitagliptin
Keywords
Diabetes Mellitus, Type 2, Canagliflozin, Placebo, 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 (Main Study) or 26 weeks (High Glycemic Substudy)

  • PlaceboDrug

    One matching placebo capsule orally once daily for 26 weeks (Main Study)

  • SitagliptinDrug

    One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)

Study groups in NCT01081834
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Receives: Drug: Canagliflozin
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 52 weeks (Main Study) or 26 weeks only (High Glycemic Substudy).
Receives: Drug: Canagliflozin
Placebo/SitagliptinExperimentalIn the Main Study, each patient will receive matching placebo once daily for 26 weeks and will then switch from placebo to 100 mg of sitagliptin once daily until Week 52.
Receives: Drug: Placebo; Drug: Sitagliptin

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 (Main Study)

    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

  2. Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

Secondary outcomes (14)

  1. Percentage of Patients With HbA1c <7% at Week 26 (Main Study)

    The table below shows the percentage of patients with HbA1c <7% at Week 26. 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 (Main Study)

    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. Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)

    The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose 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

  4. Percent Change in Body Weight From Baseline to Week 26 (Main Study)

    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

  5. Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)

    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

  6. Percent Change in Triglycerides From Baseline to Week 26 (Main Study)

    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

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

    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

  8. Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)

    The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Week 26

  9. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

  10. Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

  11. Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

  12. Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

  13. Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)

    The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    Measured: Day 1 (Baseline) and Week 26

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

    The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.

    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 posted5 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2011
  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
678 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01081834
Sponsor's protocol ID
CR017011
Other IDs
28431754DIA3005
Status last verified
Jun 2013
First submitted
4 Mar 2010
Last updated
23 Feb 2017
Data monitoring committee
Yes

Publications

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 78 sites in 18 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Lithuania, Mexico, South Korea, Philippines and 13 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 3 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 26 (Main Study) (time frame: Day 1 (Baseline) and Week 26). The study lists 2 primary outcomes in all. 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 NCT01081834, 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 23 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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