Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Belgium
State/province [18] 0 0
Aalst
Country [19] 0 0
Belgium
State/province [19] 0 0
Bonheiden
Country [20] 0 0
Belgium
State/province [20] 0 0
Brussels
Country [21] 0 0
Belgium
State/province [21] 0 0
Liège
Country [22] 0 0
Belgium
State/province [22] 0 0
Sint-Niklaas
Country [23] 0 0
Belgium
State/province [23] 0 0
Turnhout
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Brazil
State/province [25] 0 0
São Paulo
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Calgary
Country [31] 0 0
France
State/province [31] 0 0
Corbeil Essonnes
Country [32] 0 0
France
State/province [32] 0 0
La Rochelle Cedex 1 Poitou-Cha
Country [33] 0 0
France
State/province [33] 0 0
Le Creusot
Country [34] 0 0
France
State/province [34] 0 0
Nantes N/A
Country [35] 0 0
France
State/province [35] 0 0
Pierre Benite
Country [36] 0 0
France
State/province [36] 0 0
Vandoeuvre Les Nancy
Country [37] 0 0
France
State/province [37] 0 0
Venissieux
Country [38] 0 0
Germany
State/province [38] 0 0
Dormagen
Country [39] 0 0
Germany
State/province [39] 0 0
Dortmund
Country [40] 0 0
Germany
State/province [40] 0 0
Dresden
Country [41] 0 0
Germany
State/province [41] 0 0
Einbeck
Country [42] 0 0
Germany
State/province [42] 0 0
Freiburg
Country [43] 0 0
Germany
State/province [43] 0 0
Kassel
Country [44] 0 0
Germany
State/province [44] 0 0
München
Country [45] 0 0
Germany
State/province [45] 0 0
Schkeuditz
Country [46] 0 0
Germany
State/province [46] 0 0
Würzburg
Country [47] 0 0
India
State/province [47] 0 0
Aurangabad
Country [48] 0 0
India
State/province [48] 0 0
Madurai
Country [49] 0 0
India
State/province [49] 0 0
Pune
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seognam-Si, Kyungki-Do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Seoul
Country [52] 0 0
Latvia
State/province [52] 0 0
Daugavpils
Country [53] 0 0
Latvia
State/province [53] 0 0
Ogre
Country [54] 0 0
Latvia
State/province [54] 0 0
Riga
Country [55] 0 0
Malaysia
State/province [55] 0 0
Jalan Cheras N/A
Country [56] 0 0
Malaysia
State/province [56] 0 0
Kajang
Country [57] 0 0
Malaysia
State/province [57] 0 0
Kuala Lumpur N/A
Country [58] 0 0
Malaysia
State/province [58] 0 0
Pulau Pinang
Country [59] 0 0
Mexico
State/province [59] 0 0
Aguascalientes
Country [60] 0 0
Mexico
State/province [60] 0 0
Culiacan
Country [61] 0 0
Mexico
State/province [61] 0 0
Morelia
Country [62] 0 0
Mexico
State/province [62] 0 0
Zapopan
Country [63] 0 0
New Zealand
State/province [63] 0 0
Auckland
Country [64] 0 0
New Zealand
State/province [64] 0 0
Christchurch
Country [65] 0 0
New Zealand
State/province [65] 0 0
Dunedin Nz
Country [66] 0 0
New Zealand
State/province [66] 0 0
Nz
Country [67] 0 0
Poland
State/province [67] 0 0
Lask
Country [68] 0 0
Poland
State/province [68] 0 0
Lublin
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Romania
State/province [70] 0 0
Bucharest
Country [71] 0 0
Romania
State/province [71] 0 0
Targoviste
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Chelyabinsk
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Kirov
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Kursk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Nizhny Novgorod
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Petrozavodsk
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Rostov-On-Don
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Saint Petersburg
Country [80] 0 0
Russian Federation
State/province [80] 0 0
St Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Yaroslavl
Country [82] 0 0
South Africa
State/province [82] 0 0
Parow, Cape Town
Country [83] 0 0
South Africa
State/province [83] 0 0
Pretoria
Country [84] 0 0
South Africa
State/province [84] 0 0
Somerset West
Country [85] 0 0
Spain
State/province [85] 0 0
Barcelona
Country [86] 0 0
Spain
State/province [86] 0 0
Ciudad Real
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid N/A
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
San Sebastian De Los Reyes
Country [90] 0 0
Spain
State/province [90] 0 0
Santa Cruz De Tenerife
Country [91] 0 0
Spain
State/province [91] 0 0
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/study/NCT01064414
Trial related presentations / publications
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.
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.
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.
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/study/NCT01064414