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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01064414




Registration number
NCT01064414
Ethics application status
Date submitted
4/02/2010
Date registered
8/02/2010
Date last updated
14/08/2013

Titles & IDs
Public title
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Secondary ID [1] 0 0
28431754DIA3004
Secondary ID [2] 0 0
CR017008
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Canagliflozin 100 mg - Each patient will receive 100 mg of canagliflozin once daily for 52 weeks.

Experimental: Canagliflozin 300 mg - Each patient will receive 300 mg of canagliflozin once daily for 52 weeks.

Placebo Comparator: Placebo - Each patient will receive matching placebo once daily for 52 weeks.


Treatment: Drugs: Canagliflozin
One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information

Treatment: Drugs: Placebo
One matching placebo capsule orally once daily for 52 weeks in addition to the patient's AHA regimen used in accordance with local prescribing information
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

Eligibility
Key inclusion criteria
- Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy
(including oral or non oral agents)

- Patients with reduced kidney function
Minimum age
25 Years
Maximum age
No limit
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

- Have proliferative diabetic retinopathy for which treatment is planned during the
course of the study

- Kidney disease that required treatment with immunosuppressive therapy, history of
dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria
with hypoalbuminemia and/or edema), or inflammatory kidney disease

- Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen

- History of 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 assessing the outcomes
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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Reservoir
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Gosford
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- Reservoir
Recruitment outside Australia
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California
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Madrid
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Santa Cruz De Tenerife
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Valencia

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

Ethics approval
Ethics application status

Summary
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 have
reduced kidney function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01064414
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01064414