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