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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02025907




Registration number
NCT02025907
Ethics application status
Date submitted
30/12/2013
Date registered
1/01/2014
Date last updated
31/10/2016

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Scientific title
A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, 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 Sitagliptin Therapy
Secondary ID [1] 0 0
2013-004819-40
Secondary ID [2] 0 0
CR103477
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, 100 mg
Treatment: Drugs - Canagliflozin, 300 mg
Treatment: Drugs - Placebo

Experimental: Canagliflozin (JNJ-28431754) - Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.

Placebo comparator: Placebo - Each participant will receive placebo (inactive medication) once daily for 28 weeks.


Treatment: Drugs: Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.

Treatment: Drugs: Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.

Treatment: Drugs: Placebo
One placebo capsule taken orally (by mouth) once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Timepoint [1] 0 0
Baseline and Week 26
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Timepoint [1] 0 0
Baseline and Week 26
Secondary outcome [2] 0 0
Percent Change From Baseline in Body Weight at Week 26
Timepoint [2] 0 0
Baseline and Week 26
Secondary outcome [3] 0 0
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
Timepoint [3] 0 0
Week 26
Secondary outcome [4] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Timepoint [4] 0 0
Baseline and Week 26

Eligibility
Key inclusion criteria
* Must have a diagnosis of type 2 diabetes mellitus
* Must have a screening HbA1c of >=7.5% to <=10.5%
* Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
* A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
* eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
* Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
* Major surgery (ie, requiring general anesthesia) within 12 weeks 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 4
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
1/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Coffs Harbour
Recruitment hospital [2] 0 0
- Freemantle
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Herston
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Merewether
Recruitment hospital [8] 0 0
- Sherwood
Recruitment hospital [9] 0 0
- Sydney
Recruitment hospital [10] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Coffs Harbour
Recruitment postcode(s) [2] 0 0
- Freemantle
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Herston
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Merewether
Recruitment postcode(s) [8] 0 0
- Sherwood
Recruitment postcode(s) [9] 0 0
- Sydney
Recruitment postcode(s) [10] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
France
State/province [19] 0 0
La Rochelle Cedex 1 Poitou-Cha
Country [20] 0 0
France
State/province [20] 0 0
La Tronche
Country [21] 0 0
France
State/province [21] 0 0
Nancy
Country [22] 0 0
France
State/province [22] 0 0
Narbonne Cedex
Country [23] 0 0
France
State/province [23] 0 0
Nice Cedex 3
Country [24] 0 0
France
State/province [24] 0 0
Paris Cedex 15
Country [25] 0 0
France
State/province [25] 0 0
Venissieux
Country [26] 0 0
Germany
State/province [26] 0 0
Freiburg
Country [27] 0 0
Germany
State/province [27] 0 0
Fulda
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Münster
Country [30] 0 0
Germany
State/province [30] 0 0
Neuwied
Country [31] 0 0
Germany
State/province [31] 0 0
Pirna
Country [32] 0 0
Germany
State/province [32] 0 0
Speyer

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 assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.
Trial website
https://clinicaltrials.gov/study/NCT02025907
Trial related presentations / publications
Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC 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/NCT02025907