28431754DNE3001: The CREDENCE Trial
Research type
Research Study
Full title
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
IRAS ID
152231
Contact name
David Wheeler
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2013-004494-28
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, multicentre, randomised, double-blind study to find out if canagliflozin has a renal (kidney) and cardiovascular (heart blood vessels) protective effect to reduce the progression of diabetic neuropathy (damage to the kidney) and heart disease compared to placebo.
Patients with type 2 diabetes mellitus (T2DM) have an increased risk of both microvascular and macrovascular (damage to small and large blood vessels) complications which lead to morbidity and mortality. A key issue in patients with T2DM is the potential for increased blood glucose levels (hyperglycemia) which can lead to progressive damage to the kidney. Early on, this damage is reflected by small amounts of albumin in the urine that may progress to larger amounts and eventually loss of kidney function. Hyperglycemia, possibly through production of advanced glycation end products and increased blood pressure are known to be risk factors for the onset and progression of diabetic nephropathy. By virtue of its improvement in glycemic control, which has been shown to reduce albumin progression in prior studies, and effects to reduce blood pressure, canagliflozin may slow the progression of diabetic nephropathy.
Participants will be randomised to receive either canagliflozin 100mg or matching placebo in a 1:1 ratio where participants will receive their assigned treatment for the duration of the study, with the exception of a brief 2-week period, during which all patients will be treated with placebo.
The study drugs will be supplied by the sponsor, Janssen-Cilag International NV. Participants who are eligible to take part in the study may be in the study for up to 5 years and 6 months. There will be approximately 3700 patients taking part in this study worldwide.
Participants taking part in the main study will have the option to take part in an optional genetic sample for research study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1059
Date of REC Opinion
18 Jul 2014
REC opinion
Further Information Favourable Opinion