CARMELINA DM CV outcome study 1218.22
Research type
Research Study
Full title
A multicenter, international, randomized, parallel group, double blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk. CARMELINA
IRAS ID
134662
Contact name
Stephen Charles Bain
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2011-004148-23
Research summary
This is a phase 4 outcome study to compare treatment with linagliptin to placebo as add-on therapy to standard of care in patients with type 2 diabetes mellitus at high vascular risk. This study will be held at many hospitals in many countries using linagliptin and a dummy drug (placebo) which looks the same as linagliptin.
The study will evaluate Linagliptin’s cardiovascular safety and its effect on renal system, time to the first occurrence of any of the four cardiovascular events will be used. The four cardiovascular events are listed here : cardiovascular death (including fatal stroke, fatal Myocardial infarction(MI) and sudden death), non-fatal MI (excluding silent MI), non-fatal stroke and hospitalisation for unstable angina pectoris.
Once it is confirmed that there is no difference between the group of patients taking linagliptin and the group of patients taking placebo (non-inferiority has been demonstrated), then the result will be tested again to prove linagliptin is better than placebo with respect to the cardiovascular events and renal events (renal death, sustained end-stage renal disease (ESRD), sustained loss in estimated global filtration rate (eGFR) more than 50% from baseline).
A Total of 8300 patients are expected to be participate into the study (4150 patients per group) and each patient will stay in the study for 48 months from when the first patient is randomized (assigned to a treatment).
Eligible patients should be Type 2 Diabetic patients on stable daily antidiabetic medicine dose for at least 8 weeks prior to randomization and have a high risk of cardiovascular events.
Study therapy will be administered once daily as 5mg oral tablet. After study completion, patients will have access to the marketed Linagliptin if needed.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0692
Date of REC Opinion
8 Nov 2013
REC opinion
Further Information Favourable Opinion