A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study will be conducted in adults with ST-elevation myocardial infarction (STEMI) with successful revascularization following percutaneous coronary intervention (PCI) and stent implantation. Primary Objective • To evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo Secondary Objectives * To assess preliminary efficacy of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo as determined by cardiac magnetic resonance imaging (cMRI) * To determine the pharmacokinetics (PK) of dutogliptin in a subset of the study population * To establish the pharmacodynamics (PD) of dutogliptin (plasma DPP4 activity) in a subset of the study population Exploratory Objectives * To examine the effects of dutogliptin in combination with filgrastim on: * Change from baseline in plasma stromal cell-derived factor (SDF)-1a levels * Change from baseline in plasma biomarkers, including N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high sensitivity troponin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Clinical department of Cardiology
Graz, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
Safety assessment of the number of Grade 3 and 4 treatment emergent AEs or serious AEs (SAEs) as assessed by CTCAE v4.0.AEs (SAEs) as assessed by CTCAE v4.0.
Assess the tolerability of a combination of dutogliptin and filgrastim
Time frame: 90 days
Cardiovascular efficacy LVEF
Left ventricular ejection fraction (%) by MRI
Time frame: 90 days
Cardiovascular efficacy LVESV
Left ventricular end systolic volume (mL) by MRI
Time frame: 90 days
Cardiovascular efficacy LVEDV
Left ventricular end diastolic volume (mL) by MRI
Time frame: 90 days
Cardiovascular tissue damage reduction
Infarct size (mm2)
Time frame: 90 days
Cardiovascular LFM
Left ventricular mass (mm2)
Time frame: 90 days
Cardiovascular motion
Regional wall motion (mm)
Time frame: 90 days
Pharmacokinetics (PK)
Assess the systemic exposure (dutogliptin AUC) of s.c. administered dutogliptin
Time frame: 14 days
Pharmacodynamics (PD)
Assess the PD effects (plasma DPP4 activity) of s.c. administered dutogliptin
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Military Hospital
Budapest, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest, Hungary
Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika
Debrecen, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Hungary
Maasstad Ziekenhuis
Rotterdam, Netherlands
Nicolaus Copernicus University
Bydgoszcz, Poland
SPS Szpital Zachodni
Grodzisk Mazowiecki, Poland
...and 2 more locations
Time frame: 14 days