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CompletedNCT00968812Updated Jan 30, 2017Results posted

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

A Phase 3 interventional study of Glimepiride and Canagliflozin (JNJ-28431754) in Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development, LLC. Completed at 142 sites in 20 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-30.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,452
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes
  • Metformin
  • Glimepiride
  • Hemoglobin A1c
  • Type 2 diabetes mellitus
  • Canagliflozin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,452 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have a diagnosis of type 2 diabetes
  • Body mass index (BMI) >=22 to \<=45 kg/m2, at screening
  • Patients must be taking a stable dosage of metformin as monotherapy at screening
  • Patients must have a HbA1c between >=7% and \<=9.5% at Week 2
  • Patients must have a fasting plasma glucose (FPG) \<=270 mg/dL (15 mmol/L) at Week -2

Exclusion criteria

Exclusion Criteria:

  • Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
  • History of diabetic ketoacidosis or type 1 diabetes mellitus
  • History of pancreas or beta-cell transplantation
  • History of active proliferative diabetic retinopathy
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
  • Taken thiazolidinedione therapy in the past 16 weeks before screening
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,452 participants (actual)

Study arms

  • Active comparator
    Glimepiride

    Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.

    Drug: Glimepiride · Drug: Metformin

  • Experimental
    Canagliflozin 100 mg

    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

    Drug: Canagliflozin (JNJ-28431754) · Drug: Metformin

  • Experimental
    Canagliflozin 300 mg

    Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

    Drug: Canagliflozin (JNJ-28431754) · Drug: Metformin

Interventions

  • DrugGlimepiride

    Glimepiride will be given orally (by mouth), as over-encapsulated tablets, starting at a dose of 1mg once daily and increasing to a maximum of 6 mg or 8 mg once daily for 104 weeks.

    Also known as: sulfonylurea

  • DrugCanagliflozin (JNJ-28431754)

    Canagliflozin (JNJ-28431754) will be given orally as over-encapsulated tablets, at a dose of 100 mg or 300 mg once daily for 104 weeks.

  • DrugMetformin

    Metformin will be given orally at the protocol-specified dose for 104 weeks.

06

What researchers measure

Primary outcomes

  1. Change in HbA1c From Baseline to 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

    Time frame: Day 1 (Baseline) and Week 52

Secondary outcomes

  1. Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

    The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.

    Time frame: Day 1 (Baseline) and Week 52

  2. Percent Change in Body Weight From Baseline to 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.

    Time frame: Day 1 (Baseline) and Week 52

  3. Change in HbA1c From Baseline to Week 104

    The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

    Time frame: Baseline, Week 104

07

Results

Posted Jun 4, 2013
Limitations and caveats
No notable study limitations were identified by the Sponsor.

Participant flow

This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) compared with glimepiride in participants with type 2 diabetes mellitus with inadequate glycemic control despite metformin treatment. The study was conducted between 28 August 2009 and 25 January 2013 and included 157 study centers in 19 countries worldwide.

Participant flow — Overall Study
MilestoneCanagliflozin 100 mg: Baseline to Week 104Canagliflozin 300 mg: Baseline to Week 104Glimepiride: Baseline to Week 104
Started483485482
Completed343323314
Not completed140162168
Withdrew: Adverse event304633
Withdrew: Death221
Withdrew: Lack of efficacy9716
Withdrew: Lost to follow-up171211
Withdrew: Physician decision859
Withdrew: Protocol violation743
Withdrew: Withdrawal by subject172325
Withdrew: Creatinine or egfr withdrawal criteria9137
Withdrew: Noncompliance with study drug416
Withdrew: Unable to take rescue therapy121217
Withdrew: Other253740

Outcome measures

PrimaryChange in HbA1c From Baseline to 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

Time frame:
Day 1 (Baseline) and Week 52
Reported as:
Least squares mean · Percent
Change in HbA1c From Baseline to Week 52
PercentCanagliflozin 100 mgCanagliflozin 300 mgGlimepiride
Change in HbA1c From Baseline to Week 52-0.82 ± 0.039-0.93 ± 0.039-0.81 ± 0.039
Statistical analysis
  • Canagliflozin 100 mg vs Glimepiride · ANCOVA · Least-squares mean difference: -0.01 · 95% CI -0.109 to 0.085
  • Canagliflozin 300 mg vs Glimepiride · ANCOVA · Least-squares mean difference: -0.12 · 95% CI -0.217 to -0.023
SecondaryPercentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.

Time frame:
Day 1 (Baseline) and Week 52
Reported as:
Number · Percentage of patients
Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52
Percentage of patientsCanagliflozin 100 mgCanagliflozin 300 mgGlimepiride
Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 525.64.934.2
Statistical analysis
  • Canagliflozin 100 mg vs Glimepiride · Regression, Logistic · p = <0.001 · Odds ratio (or): 0.10 · 95% CI 0.06 to 0.16
  • Canagliflozin 300 mg vs Glimepiride · Regression, Logistic · p = <0.001 · Odds ratio (or): 0.09 · 95% CI 0.05 to 0.14
SecondaryPercent Change in Body Weight From Baseline to 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.

Time frame:
Day 1 (Baseline) and Week 52
Reported as:
Least squares mean · Percent change
Percent Change in Body Weight From Baseline to Week 52
Percent changeCanagliflozin 100 mgCanagliflozin 300 mgGlimepiride
Percent Change in Body Weight From Baseline to Week 52-4.2 ± 0.2-4.7 ± 0.21.0 ± 0.2
Statistical analysis
  • Canagliflozin 100 mg vs Glimepiride · ANCOVA · p = <0.001 · Least-squares mean difference: -5.2 · 95% CI -5.7 to -4.7
  • Canagliflozin 300 mg vs Glimepiride · ANCOVA · p = <0.001 · Least-squares mean difference: -5.7 · 95% CI -6.2 to -5.1
SecondaryChange in HbA1c From Baseline to Week 104

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.

Time frame:
Baseline, Week 104
Reported as:
Least squares mean · Percent
Change in HbA1c From Baseline to Week 104
PercentCanagliflozin 100 mgCanagliflozin 300 mgGlimepiride
Change in HbA1c From Baseline to Week 104-0.65 ± 0.042-0.74 ± 0.042-0.55 ± 0.043
Statistical analysis
  • Canagliflozin 100 mg vs Glimepiride · ANCOVA · Least-squares mean difference: -0.09 · 95% CI -0.200 to 0.010
  • Canagliflozin 300 mg vs Glimepiride · ANCOVA · Least-squares mean difference: -0.18 · 95% CI -0.289 to -0.078

Adverse events

Collected over Adverse event data were collected for the duration of the study (104 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Canagliflozin 100 mg: Baseline to Week 52—24/483 (5%)138/483 (28.6%)
Canagliflozin 300 mg: Baseline to Week 52—26/485 (5.4%)150/485 (30.9%)
Glimepiride: Baseline to Week 52—39/482 (8.1%)175/482 (36.3%)
Canagliflozin 100 mg: Baseline to Week 104—47/483 (9.7%)198/483 (41%)
Canagliflozin 300 mg: Baseline to Week 104—47/485 (9.7%)204/485 (42.1%)
Glimepiride: Baseline to Week 104—69/482 (14.3%)242/482 (50.2%)
Most frequent serious events
Showing 10 of 157
Most frequent serious events
EventCanagliflozin 100 mg: Baseline to Week 52Canagliflozin 300 mg: Baseline to Week 52Glimepiride: Baseline to Week 52Canagliflozin 100 mg: Baseline to Week 104Canagliflozin 300 mg: Baseline to Week 104Glimepiride: Baseline to Week 104
CholelithiasisHepatobiliary disorders0/4830/4853/4820/4830/4854/482
Angina pectorisCardiac disorders1/4832/4852/4823/4832/4853/482
Non-cardiac chest painGeneral disorders0/4831/4852/4820/4832/4853/482
Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/4832/4850/4820/4833/4850/482
Angina unstableCardiac disorders0/4831/4851/4821/4831/4852/482
Atrial fibrillationCardiac disorders0/4830/4851/4820/4830/4852/482
Coronary artery diseaseCardiac disorders0/4830/4851/4821/4830/4852/482
CataractEye disorders1/4830/4850/4821/4830/4852/482
AppendicitisInfections and infestations0/4830/4852/4820/4830/4852/482
PneumoniaInfections and infestations1/4831/4852/4821/4832/4852/482
Most frequent other events
Showing 10 of 11
Most frequent other events
EventCanagliflozin 100 mg: Baseline to Week 52Canagliflozin 300 mg: Baseline to Week 52Glimepiride: Baseline to Week 52Canagliflozin 100 mg: Baseline to Week 104Canagliflozin 300 mg: Baseline to Week 104Glimepiride: Baseline to Week 104
HypoglycaemiaMetabolism and nutrition disorders15/4839/48561/48217/48316/48586/482
Upper respiratory tract infectionInfections and infestations17/48327/48541/48236/48338/48556/482
NasopharyngitisInfections and infestations33/48337/48537/48247/48355/48551/482
Urinary tract infectionInfections and infestations26/48323/48518/48244/48333/48527/482
DiarrhoeaGastrointestinal disorders24/48333/48529/48225/48239/48534/482
Back painMusculoskeletal and connective tissue disorders29/48318/48520/48234/48328/48526/482
HeadacheNervous system disorders14/48325/48524/48221/48329/48533/482
HypertensionVascular disorders8/48310/48513/48215/48311/48530/482
NauseaGastrointestinal disorders16/48325/48513/48220/48327/48519/482
ArthralgiaMusculoskeletal and connective tissue disorders18/48313/48518/48226/48316/48524/482

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Canagliflozin 100 mgCanagliflozin 300 mgGlimepirideTotal
<=18 years0000
Between 18 and 65 years3974113991207
>=65 years867483243
Age, Continuous
Age, Continuous(years)Canagliflozin 100 mgCanagliflozin 300 mgGlimepirideTotal
Mean56.4 ± 9.4955.8 ± 9.1756.3 ± 9.0156.2 ± 9.22
Gender
Gender(Participants)Canagliflozin 100 mgCanagliflozin 300 mgGlimepirideTotal
Female231244219694
Male252241263756
Region Enroll
Region Enroll(participants)Canagliflozin 100 mgCanagliflozin 300 mgGlimepirideTotal
ARGENTINA18181854
BULGARIA77721
CANADA19201958
COSTA RICA109928
DENMARK24252574
FINLAND18171954
GERMANY67619
INDIA555556166
ISRAEL14151443
MEXICO24252473
NORWAY99927
PHILIPPINES14131340
POLAND14151544
ROMANIA434344130
RUSSIAN FEDERATION23222267
SLOVAKIA15141342
SOUTH KOREA31323194
UKRAINE22222266
UNITED STATES117117116350
08

Study locations

142 sites
  • Calera, Alabama, United States
  • Gilbert, Arizona, United States
  • Mesa, Arizona, United States
  • Tucson, Arizona, United States
  • Jonesboro, Arkansas, United States
  • Buena Park, California, United States
  • Encinitas, California, United States
  • Fresno, California, United States
  • Lincoln, California, United States
  • Roseville, California, United States
  • San Diego, California, United States
  • Westlake Village, California, United States
  • Chipley, Florida, United States
  • Marianna, Florida, United States
  • Oldsmar, Florida, United States
  • Orlando, Florida, United States
  • Augusta, Georgia, United States
  • Perry, Georgia, United States
  • Nampa, Idaho, United States
  • Chicago, Illinois, United States
  • Vernon Hills, Illinois, United States
  • Valparaiso, Indiana, United States
  • New Orleans, Louisiana, United States
  • Elkridge, Maryland, United States
  • Bloomfield Hills, Michigan, United States
  • Las Vegas, Nevada, United States
  • Canal Fulton, Ohio, United States
  • Gallipolis, Ohio, United States
  • Mason, Ohio, United States
  • Perrysburg, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Yukon, Oklahoma, United States
  • Fleetwood, Pennsylvania, United States
  • Greenville, South Carolina, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Odessa, Texas, United States
  • Pearland, Texas, United States
  • San Antonio, Texas, United States
  • Danville, Virginia, United States
  • Olympia, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Wauwatosa, Wisconsin, United States
  • Buenos Aires, Argentina
  • Ciudad Autonoma De Buenos Aires, Argentina
  • Mar Del Plata, Argentina
  • Rosario, Argentina
  • Dimitrovgrad, Bulgaria
  • Kazanlak, Bulgaria
  • Rousse, Bulgaria
  • Sofia, Bulgaria
  • Chilliwack, British Columbia, Canada
  • Kelowna, British Columbia, Canada
  • Vancouver, British Columbia, Canada
  • St. John'S, Newfoundland and Labrador, Canada
  • Mississauga, Ontario, Canada
  • Toronto, Ontario, Canada
  • Saskatoon, Saskatchewan, Canada
  • Quebec, Canada
  • San Jose, Costa Rica
  • San Pedro, Costa Rica
  • Aalborg, Denmark
  • Ballerup, Denmark
  • Vejle, Denmark
  • Vipperoed, Denmark
  • Helsinki, Finland
  • Kokkola, Finland
  • Kuopio, Finland
  • Oulu, Finland
  • Turku, Finland
  • Berlin, Germany
  • Dresden, Germany
  • Duesseldorf, Germany
  • Hamburg, Germany
  • Mainz, Germany
  • Villingen-Schwenningen, Germany
  • Bangalore, India
  • Chennai, India
  • Coimbatore, India
  • Hyderabad, India
  • Nagpur, India
  • Pune, India
  • Wardha, India
  • Beer Sheba, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Ramat Gan, Israel
  • Rehovot, Israel
  • Tel Aviv, Israel
  • Tel-Aviv, Israel
  • Zefat, Israel
  • Daegu, Korea, Republic of
  • Goyang-Si, Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of
  • Incheon, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
  • Wonju-Si, Korea, Republic of
  • Wonju, Korea, Republic of

Showing the first 100 of 142 sites across 20 countries.

09

References and documents

Publications

  • Heerspink HJL, Perco P, Mulder S, Leierer J, Hansen MK, Heinzel A, Mayer G. Canagliflozin reduces inflammation and fibrosis biomarkers: a potential mechanism of action for beneficial effects of SGLT2 inhibitors in diabetic kidney disease. Diabetologia. 2019 Jul;62(7):1154-1166. doi: 10.1007/s00125-019-4859-4. Epub 2019 Apr 17. PubMed 31001673 ↗
  • Garvey WT, Van Gaal L, Leiter LA, Vijapurkar U, List J, Cuddihy R, Ren J, Davies MJ. Effects of canagliflozin versus glimepiride on adipokines and inflammatory biomarkers in type 2 diabetes. Metabolism. 2018 Aug;85:32-37. doi: 10.1016/j.metabol.2018.02.002. Epub 2018 Feb 13. PubMed 29452178 ↗
  • 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 ↗
  • Patel CA, Bailey RA, Vijapurkar U, Meininger G, Blonde L. A post-hoc analysis of the comparative efficacy of canagliflozin and glimepiride in the attainment of type 2 diabetes-related quality measures. BMC Health Serv Res. 2016 Aug 5;16(a):356. doi: 10.1186/s12913-016-1607-z. PubMed 27495291 ↗
  • Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7. PubMed 27002421 ↗
  • Leiter LA, Langslet G, Vijapurkar U, Davies MJ, Canovatchel W. Simultaneous Reduction in Both HbA1c and Body Weight with Canagliflozin Versus Glimepiride in Patients with Type 2 Diabetes on Metformin. Diabetes Ther. 2016 Jun;7(2):269-78. doi: 10.1007/s13300-016-0163-1. Epub 2016 Mar 16. PubMed 26984361 ↗
  • 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 ↗
  • Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9. PubMed 25205142 ↗
  • 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 ↗
  • Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12. PubMed 23850055 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00968812
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Aug 31, 2009
Start date
Sep 2009
Primary completion
Dec 2011
Completion
Jan 2013
Results posted
Jun 4, 2013
Last update
Jan 30, 2017

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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