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Diabetes Mellitus, Type 2Phase 3NCT01106690

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

A Phase 3 study testing Canagliflozin, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 83 sites in 11 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 receving treatment with metformin and pioglitazone 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, Sitagliptin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
344 participants
Where
83 sitesin 11 countries
Study dates
Jun 2010to Jul 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 PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
  • Patients in the study must have a HbA1c between >=7 and <=10.5% and 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

83 sites in 11 countries.

83 sites in 11 countries

United States41 sites

  • Study site

    Anniston, Alabama

  • Study site

    Arlington, Texas

  • Study site

    Bartow, Florida

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Billings, Montana

  • Study site

    Bristol, Tennessee

  • Study site

    Burlingame, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Chaska, Minnesota

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    Des Moines, Iowa

  • Study site

    Dublin, Ohio

  • Study site

    Encinitas, California

  • Study site

    Falls Church, Virginia

  • Study site

    Federal Way, Washington

  • Study site

    Fullerton, California

  • Study site

    Grand Prairie, Texas

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kingsport, Tennessee

  • Study site

    Little Rock, Arkansas

  • Study site

    Nashville, Tennessee

  • Study site

    New Braunfels, Texas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perrysburg, Ohio

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Raleigh, North Carolina

  • Study site

    Roseville, California

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Selah, Washington

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Virginia Beach, Virginia

  • Study site

    Wes Hills, California

  • Study site

    Yukon, Oklahoma

Other trials in United States

Canada12 sites

  • Study site

    Bathurst, New Brunswick

  • Study site

    Brampton, Ontario

  • Study site

    Calgary

  • Study site

    Drummondville, Quebec

  • Study site

    Grand Falls-Windsor, Newfoundland and Labrador

  • Study site

    Hamilton, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Mount Pearl

  • Study site

    Ottawa, Ontario

  • Study site

    Smiths Falls, Ontario

  • Study site

    Thornhill, Ontario

  • Study site

    Truro

Other trials in Canada

India6 sites

  • Study site

    Ahmedabad

  • Study site

    Belagavi

  • Study site

    Chennai

  • Study site

    Coimbatore

  • Study site

    Jaipur

  • Study site

    Nagpur

Other trials in India

Germany4 sites

  • Study site

    Aschaffenburg

  • Study site

    Mainz

  • Study site

    Neuwied

  • Study site

    Schkeuditz

Other trials in Germany

Mexico4 sites

  • Study site

    Chihuahua City

  • Study site

    Ciudad Juárez

  • Study site

    Durango

  • Study site

    México

Other trials in Mexico

Finland3 sites

  • Study site

    Kuopio

  • Study site

    Oulu

  • Study site

    Turku

Other trials in Finland

France3 sites

  • Study site

    Bondy

  • Study site

    Le Creusot

  • Study site

    Narbonne

Other trials in France

Greece3 sites

  • Study site

    Athens

  • Study site

    Thessaloniki

  • Study site

    Thessalonikis

Other trials in Greece

Spain3 sites

  • Study site

    Almería

  • Study site

    Madrid

  • Study site

    Seville

Other trials in Spain

Thailand2 sites

  • Study site

    Bangkok

  • Study site

    Khon Kaen

Other trials in Thailand

United Kingdom2 sites

  • Study site

    Antrim

  • Study site

    Belfast

Other trials in United Kingdom

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 Pioglitazone 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 receving treatment with metformin and pioglitazone 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), 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 pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance 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 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. 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) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks.

Being tested
Placebo, Canagliflozin, Sitagliptin, Metformin, Pioglitazone
Keywords
Canagliflozin, Placebo, Sitagliptin (Januvia), Metformin, Pioglitazone (Actos), 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.

  • PlaceboDrug

    One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.

  • CanagliflozinDrug

    One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.

  • SitagliptinDrug

    One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.

  • MetforminDrug

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

  • PioglitazoneDrug

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

Study groups in NCT01106690
Study groupRoleWhat they receive
Placebo/SitagliptinOtherEach patient will receive matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients will be switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
Receives: Drug: Placebo; Drug: Sitagliptin; Drug: Metformin; Drug: Pioglitazone
Canagliflozin 100 mgExperimentalEach patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Receives: Drug: Canagliflozin; Drug: Metformin; Drug: Pioglitazone
Canagliflozin 300 mgExperimentalEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Receives: Drug: Canagliflozin; Drug: Metformin; Drug: Pioglitazone

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 (7)

  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. Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26

    HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B 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

    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

    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

    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

    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 startJun 2010
  3. Primary completionNov 2011
  4. Study completionJul 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
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01106690
Sponsor's protocol ID
CR017032
Other IDs
28431754DIA3012
Status last verified
Jun 2013
First submitted
1 Apr 2010
Last updated
15 Jul 2013
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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 83 sites in 11 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 2 inclusion and 2 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 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada, India, Germany, Mexico and 6 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 21 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 NCT01106690, which also lists 14 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 15 Jul 2013.

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