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Cancer risk in type 2 diabetes patients treated with sulfonylurea.


- candidate number26348
- NTR NumberNTR6166
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2017
- Secondary IDsZODIAC-55, METC 13.0765 
- Public TitleCancer risk in type 2 diabetes patients treated with sulfonylurea.
- Scientific TitleWithin-class differences in cancer risk for sulfonylurea treatments in patients with type 2 diabetes (ZODIAC-55)
- ACRONYMZODIAC-55
- hypothesisPatients with Type 2 diabetes have been shown to have an increased risk for developing cancer, especially obesity related cancers. There is some evidence that within the class of sulfonylureas there is a difference in cancer risk; gliclazide could be associated with a decreased cancer risk when compared to the other sulfonylureas.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Cancer
- Inclusion criteriaType 2 diabetes patients treated with sulfonylureas
- Exclusion criteriaType 2 diabtes patientes treated with long-acting or mixed insulin before oral glucose lowering agents and those receiving insulin on top of sulfonylurea at study entry.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 30-jan-2017
- planned closingdate
- Target number of participants0
- InterventionsIndividual sulfonylurea treatment (gliclazide, glimepiride, tolbutamide, glibenclamide)
- Primary outcomeWithin-sulfonylurea-class differences in obesity-related cancer risk (hazard ratio).
- Secondary outcomeWithin-sulfonylurea-class differences in all cancer risk and site specific cancer risk of breast, colorectal, bladder, advanced prostate cancer and lung cancer, expressed as hazard ratio.
- TimepointsHazard ratio will be calculated for a period up to 10 years.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Dennis Schrijnders
- CONTACT for SCIENTIFIC QUERIES Dennis Schrijnders
- Sponsor/Initiator Diabetes Centre, Isala
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-jan-2017 - 12-feb-2017


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