The CAROLINA Trial. Final Protocol, Version 1, 17 Aug 2010
Research type
Research Study
Full title
A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk.
IRAS ID
52708
Contact name
Stephen Charles Bain
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2009-013157-15
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Historically, the emergence of cardiovascular side effect warnings in the classes of medicines used to treat type 2 diabetes, have only occurred at a relatively late stage in the development process, such as just before, or even after, the medicine has already reached the market. With this in mind, the regulating authorities have issued some guidance in order to rule out potential excessive morbidity and mortality associated with all new medicines for the treatment of this patient population. This study will look at the safety of linagliptin, a new medicine which lowers blood sugar levels in patients with type 2 diabetes. The study is particularly looking at patients who are at an increased risk of cardiovascular (heart and/or blood vessel) events. This new drug is being compared to glimepiride which is a commonly prescribed Sulphonylurea. Sulphonylureas are a type of oral antidiabetic medicine that stimulates insulin secretion from the pancreatic cells. The two medications will be compared as a single medicine therapy, or as an additional therapy to current antidiabetic treatments already being taken by the patients. The patient will initially undertake a 2 - 4 week period where they will be taking two placebo (dummy) medications. This is necessary as the two medications look physically different. They will take one linagliptin placebo tablet and one glimepiride placebo capsule. Once that phase has been completed successfully the patient will be randomly allocated to treatment with either linagliptin (5mg once daily) or to treatment with a glimepiride (1-4mg).Half the patients will receive linagliptin and half glimepiride. Patients will be reviewed every 4 weeks for the first 4 months then at 16 weekly intervals until the end of the study.It is anticipated that the trial duration will be approximately 7.5 years (406 weeks).In the UK, the study will run in both hospitals and GP practices.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
10/H0505/108
Date of REC Opinion
14 Jan 2011
REC opinion
Further Information Favourable Opinion