The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)
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
2 other identifiers
interventional
344
11 countries
83
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Jun 2010
Typical duration for phase_3 diabetes-mellitus-type-2
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
May 21, 2013
CompletedJuly 15, 2013
June 1, 2013
1.4 years
April 1, 2010
April 2, 2013
June 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 1 (Baseline) and Week 26
Secondary Outcomes (7)
Percentage of Patients With HbA1c <7% at Week 26
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Day 1 (Baseline) and Week 26
Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26
Day 1 (Baseline) and Week 26
Percent Change in Body Weight From Baseline to Week 26
Day 1 (Baseline) and Week 26
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Day 1 (Baseline) and Week 26
- +2 more secondary outcomes
Study Arms (3)
Placebo/Sitagliptin
OTHEREach 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.
Canagliflozin 100 mg
EXPERIMENTALEach patient will receive 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Canagliflozin 300 mg
EXPERIMENTALEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
Interventions
One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.
One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.
One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.
The patient's stable dose of metformin background therapy should be continued throughout the study.
The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
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Anniston, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Burlingame, California, United States
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Encinitas, California, United States
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Fullerton, California, United States
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Roseville, California, United States
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Santa Ana, California, United States
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Wes Hills, California, United States
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Colorado Springs, Colorado, United States
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Bartow, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Des Moines, Iowa, United States
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Baton Rouge, Louisiana, United States
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Chaska, Minnesota, United States
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Picayune, Mississippi, United States
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Billings, Montana, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Dublin, Ohio, United States
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Perrysburg, Ohio, United States
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Tulsa, Oklahoma, United States
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Yukon, Oklahoma, United States
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Bensalem, Pennsylvania, United States
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Bristol, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Grand Prairie, Texas, United States
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Houston, Texas, United States
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New Braunfels, Texas, United States
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San Antonio, Texas, United States
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Falls Church, Virginia, United States
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Virginia Beach, Virginia, United States
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Federal Way, Washington, United States
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Selah, Washington, United States
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Bathurst, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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Grand Falls-Windsor, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Thornhill, Ontario, Canada
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Drummondville, Quebec, Canada
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Calgary, Canada
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Mount Pearl, Canada
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Truro, Canada
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Kuopio, Finland
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Oulu, Finland
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Turku, Finland
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Bondy, France
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Le Creusot, France
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Narbonne, France
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Aschaffenburg, Germany
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Mainz, Germany
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Neuwied, Germany
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Schkeuditz, Germany
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Athens, Greece
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Thessaloniki, Greece
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Thessalonikis, Greece
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Ahmedabad, India
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Belagavi, India
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Chennai, India
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Coimbatore, India
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Jaipur, India
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Nagpur, India
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Chihuahua City, Mexico
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Ciudad Juárez, Mexico
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Durango, Mexico
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México, Mexico
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Almería, Spain
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Madrid, Spain
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Seville, Spain
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Bangkok, Thailand
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Khon Kaen, Thailand
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Antrim, United Kingdom
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Belfast, United Kingdom
Related Publications (14)
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.
PMID: 28327140DERIVEDPfeifer 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.
PMID: 28241822DERIVEDGilbert 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.
PMID: 28197834DERIVEDQiu 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.
PMID: 27977934DERIVEDJohn 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.
PMID: 27600862DERIVEDWatts 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.
PMID: 26580237DERIVEDBlonde 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.
PMID: 26373629DERIVEDGavin 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.
PMID: 26121561DERIVEDCefalu 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.
PMID: 25813214DERIVEDWeir 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.
PMID: 25329038DERIVEDUsiskin 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.
PMID: 24918789DERIVEDWeir 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.
PMID: 24786834DERIVEDSinclair 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.
PMID: 24742013DERIVEDNyirjesy 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.
PMID: 24517339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 20, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
July 1, 2012
Last Updated
July 15, 2013
Results First Posted
May 21, 2013
Record last verified: 2013-06