PHASE 2B STUDY IN AMI (REC-DUT-002)
REC-DUT-002 is a global multicenter, double-blind, randomized, placebo-controlled trial that evaluated the safety and initial efficacy of dutogliptin in combination with G-CSF as an adjunct treatment for patients in early recovery following an Acute Myocardial Infarction (AMI).
Status of Study
The patient treatment and follow-up phases of this study approved by the FDA and carried out in several European countries has been concluded.
Based on the pre-clinical determination of efficacy, the establishment of safety, tolerability, and pharmacokinetics of dutogliptin in healthy subjects, and the extensive clinical experience with G-CSF for stem cell mobilization, the study evaluated dutogliptin and G-CSF in patients who had an AMI and received successful initial treatment with PCI and stent placement. G-CSF is used to mobilize stem cells from the bone marrow to circulating blood while dutogliptin activates stem cell migration and homing from blood to the site of ischemia or injury in the heart. The study was seeking primarily to determine safety and the capacity to improve heart function using cardiac MRI for evaluation.
The study was designed as a double-blind, randomized, placebo-controlled trial (Phase 2B).
Patients who participated in this study were those who had a large myocardial infarction (STEMI) due to coronary artery atherosclerotic disease where treatment could be initiated within 36 hours of the STEMI. Specific eligibility criteria are listed in the link below. After completion of screening procedures, patients were randomized to receive either dutogliptin in combination with G-CSF or placebo.
Information and Contacts
For more information about this clinical study, visit the following link: