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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01106625




Registration number
NCT01106625
Ethics application status
Date submitted
1/04/2010
Date registered
20/04/2010
Date last updated
20/06/2013

Titles & IDs
Public title
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Scientific 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
Secondary ID [1] 0 0
28431754DIA3002
Secondary ID [2] 0 0
CR017005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Canagliflozin
Treatment: Drugs - Placebo
Treatment: Drugs - Metformin
Treatment: Drugs - Sulphonylruea

Experimental: Canagliflozin 100 mg - Each patient will receive 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Experimental: Canagliflozin 300 mg - Each patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.

Placebo comparator: Placebo - Each patient will receive matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.


Treatment: Drugs: Canagliflozin
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.

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

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

Treatment: Drugs: Sulphonylruea
The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26
Timepoint [1] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [1] 0 0
Percentage of Patients With HbA1c <7% at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [2] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Timepoint [2] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [3] 0 0
Percent Change in Body Weight From Baseline to Week 26
Timepoint [3] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [4] 0 0
Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
Timepoint [4] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [5] 0 0
Percent Change in Triglycerides From Baseline to Week 26
Timepoint [5] 0 0
Day 1 (Baseline) and Week 26
Secondary outcome [6] 0 0
Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
Timepoint [6] 0 0
Day 1 (Baseline) and Week 26

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
469
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Freemantle
Recruitment hospital [2] 0 0
- Heidelberg Heights
Recruitment hospital [3] 0 0
- Meadowbrook
Recruitment hospital [4] 0 0
- Nedlands
Recruitment hospital [5] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Freemantle
Recruitment postcode(s) [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [3] 0 0
- Meadowbrook
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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State/province [2] 0 0
Alaska
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Maryland
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Missouri
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North Carolina
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Vermont
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Washington
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Belgium
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Aalst
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Belgium
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Bonheiden
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Edegem
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Leuven
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France
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La Rochelle
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France
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Le Creusot
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Poitiers
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France
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Venissieux
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Guatemala
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Guatemala
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Balatonfured
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Budapest
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Gyor
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Haifa
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Holon
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Guadalajara
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Carolina
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Trujillo Alto
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Bolton
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Liverpool
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC C. Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01106625