A study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus

• Register: EUCTR
• Last refreshed on: 16 October 2017
• Main ID: EUCTR2013-003050-25-CZ
• Date of registration: 09/01/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus
• Scientific title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus
• Date of first enrolment: 01/04/2014
• Target sample size: 5700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003050-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen Research & Development

• Name: Clinical Registry Group
• Affiliation: Janssen Research & Development

Key inclusion & exclusion criteria

Inclusion criteria:
1. Must have a diagnosis of type 2 diabetes mellitus.
2. Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening)
3. History or high risk of CV events.
4. Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2280

Exclusion criteria:
1. History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of one or more severe hypoglycemic episode within 6 months before screening.
3. History of hereditary glucose-galactose malabsorption or primary renal glucosuria.
4. Ongoing, inadequately controlled thyroid disorder.
5. Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant
6. Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with type 2 diabetes mellitus (T2DM) receiving standard of care but with inadequate glycemic control and at elevated risk of cardiovascular (CV) events
MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Invokana
Product Name: Canagliflozin
Product Code: JNJ-28431754
Pharmaceutical Form: Capsule
INN or Proposed INN: Canagliflozin
CAS Number: 928672-86-0
Current Sponsor code: JNJ-28431754
Other descriptive name: Canagliflozin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Trade Name: Invokana
Product Name: Canagliflozin
Product Code: JNJ-28431754
Pharmaceutical Form: Capsule
INN or Proposed INN: Canagliflozin
CAS Number: 928672-86-0
Current Sponsor code: JNJ-28431754
Other descriptive name: Canagliflozin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: 1. To assess the effect of canagliflozin compared to placebo on progression of albuminuria.

Timepoint(s) of evaluation of this end point: 1. Baseline, Week 26, 52, 78, 104, 156

Secondary Objective: To assess the effect of canagliflozin compared to placebo on:
1. Regression of albuminuria
2. Estimated glomerular filtration rate (eGFR)
3. Urinary albumin/creatinine ratio

Primary end point(s): 1. Number of participants with progression of albuminuria

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Baseline, Week 26, 52, 78, 104, 156
2. Baseline, up to Day 30 of post treatment follow-up
3. Baseline, Week 156

Secondary end point(s): 1. Number of participants with regression of albuminuria
2. Change in estimated glomerular filtration rate (eGFR) from baseline to the last off-treatment measurement.
3. Urinary albumin/creatinine ratio at last on-treatment visit

Secondary ID(s)

2013-003050-25-SE

28431754DIA4003

Source(s) of Monetary Support

Janssen Research & Development LLC