Acute Myocardial InfarctionPhase 2NCT03486080
Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction
A Phase 2 study testing Dutogliptin Tartrate and Filgrastim Injectable Product in people with Acute Myocardial Infarction and Acute Myocardial Ischemia, run by Recardio, Inc. at 12 sites in 5 countries.
Trial summary
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocardial Infarction, Acute Myocardial Ischemia, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Dutogliptin Tartrate and Filgrastim Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 7 Dec 2018to 26 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female born between 1933 and 2000.
- Body weight <96 kg (212 lb).
- Able to provide written informed consent, including signing and dating the informed consent form (ICF).
- Diagnosis of STEMI (defined as new ST-segment elevation at the J point of at least 2 continuous leads of >2 mm [0.2 mV] in men or >1.5 mm [0.1 mV] in women in leads V2 and V3 OR >1 mm in any other contiguous precordial leads or the limb leads [for both men and women]) with PCI (bare metal or drug-eluting stent) and Thrombolysis in Myocardial Infarction flow grade 2 or 3 occurring >2 hours and <24 hours after symptom onset.
- LVEF ≤45% obtained by cECHO performed within 36 hours post-stent placement.
- Receiving standard medical therapy for post-MI treatment, according to local procedures and Principal Investigator discretion
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation.
- Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a bilateral oophorectomy, hysterectomy, or tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study.
Who cannot join
- Previous MI prior to Screening.
- Complex peri/post-MI clinical course, including arrhythmias, cardiogenic shock, pulmonary edema requiring mechanical ventilation, or requirement for vasopressor medications.
- Significant pre-existing cardiomyopathy with known LVEF ≤45% or moderate to severe mitral or aortic valvular disease.
- Amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- Existing heart transplant.
- Ventricular tachycardia or fibrillation not associated with an acute ischemic episode.
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- Uncontrolled hypertension (systolic >180 mmHg or diastolic >120 mmHg).
- Treatment with any DPP4 inhibitors (e.g., alogliptin, linagliptin, vildagliptin, saxagliptin, sitagliptin) or G-CSF medication (e.g., filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to Randomization.
- Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication.
- Anemia defined as hemoglobin <9 g/dL prior to Randomization.
- Thrombocytosis (platelets >500 k/µL).
- Known positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Alanine aminotransferase (ALT) concentrations >3 times the upper limit of normal (ULN) or bilirubin >2 x ULN prior to Randomization, according to local laboratory assessments.
- History of cirrhosis and Child-Pugh score B or C.
- Current fever greater than 101.4 °F (38.6 °C) or recent systemic infection within 2 weeks prior to Randomization.
- Contraindication to cMRI procedure, including prior implantable cardioverter defibrillator placement, known reaction to gadolinium, claustrophobia, non-MRI-compatible, cochlear implant, morbid obesity, or presence of ferromagnetic material including shunts, shrapnel, penile prostheses, or blood vessel coil.
- Pregnant, planning to become pregnant, or nursing female subjects.
- Autoimmune disease requiring immunosuppressive therapy or chronic steroid treatment >5 mg/day prednisolone or equivalent.
- Significant renal impairment defined as estimated glomerular filtration rate <45 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration equation.
- Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to Screening with no detectable recurrence are allowed).
- Malignant hematological disease, i.e., chronic myeloid leukemia or myelodysplastic syndrome.
- History of cerebrovascular accident or transient ischemic attack in the past 6 months.
- History of pneumonia in the last 4 weeks.
- History of any significant medical or psychiatric disorder that in the opinion of the investigator would make the subject unsuitable for participation in the study.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) or treatment with an investigational biologic drug within 6 weeks prior to randomization.
- Participation in another concurrent clinical trial involving a therapeutic intervention (participation in observational studies and/or registry studies is permitted).
- Unable or unwilling to comply with the requirements of the study.
- Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
- Considered by the investigator to be unsuitable to participate in the study for any other reason.
- Persons who are in an institution as a result of an administrative or judicial order, or soldiers.
- History of alcohol or drug abuse.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Hungary4 sites
Military Hospital
Budapest
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest
Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika
Debrecen
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
Miskolc
Poland4 sites
Nicolaus Copernicus University
Bydgoszcz
SPS Szpital Zachodni
Grodzisk Mazowiecki, 05-825
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi ul. Pomorska 251
Lodz, 92-213
Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II
Zamość
Austria2 sites
Clinical department of Cardiology
Graz
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination With Filgrastim in Early Recovery Post-Myocardial Infarction
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
Read the detailed description
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
- Conditions
- Acute Myocardial Infarction, Acute Myocardial Ischemia, STEMI - ST Elevation Myocardial Infarction
- Being tested
- Dutogliptin Tartrate, Filgrastim Injectable Product, Placebos
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutogliptin TartrateDrug
Also called dutogliptin
Active treatment
Filgrastim Injectable ProductDrug
Also called filgrastim
Active treatment
PlacebosDrug
Also called placebo
placebo control
| Study group | Role | What they receive |
|---|---|---|
| Dutogliptin/filgrastim combination | Active comparator | Twice daily SC injections of 60 mg dutogliptin tartrate for 14 days in combination with 10 µg/kg filgrastim injectable product for 5 days Receives: Drug: Dutogliptin Tartrate; Drug: Filgrastim Injectable Product |
| Placebo control | Placebo comparator | Twice daily dutogliptin SC placebos for 14 days in combination with matching filgrastim SC placebos for 5 days Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (8)
Cardiovascular efficacy LVEF
Left ventricular ejection fraction (%) by MRI
Measured: 90 days
Cardiovascular efficacy LVESV
Left ventricular end systolic volume (mL) by MRI
Measured: 90 days
Cardiovascular efficacy LVEDV
Left ventricular end diastolic volume (mL) by MRI
Measured: 90 days
Cardiovascular tissue damage reduction
Infarct size (mm2)
Measured: 90 days
Cardiovascular LFM
Left ventricular mass (mm2)
Measured: 90 days
Cardiovascular motion
Regional wall motion (mm)
Measured: 90 days
Pharmacokinetics (PK)
Assess the systemic exposure (dutogliptin AUC) of s.c. administered dutogliptin
Measured: 14 days
Pharmacodynamics (PD)
Assess the PD effects (plasma DPP4 activity) of s.c. administered dutogliptin
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start7 Dec 2018
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recardio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Schenk, MD, Study chair, Recardio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486080
- Sponsor's protocol ID
- REC-DUT-002
- Status last verified
- May 2021
- First submitted
- 12 Mar 2018
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination With Filgrastim in Early Recovery Post-Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03486080
- Acronym / sponsor ID
- REC-DUT-002
- Conditions
- Acute Myocardial Infarction, Acute Myocardial Ischemia, STEMI - ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Recardio, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutogliptin/filgrastim combination | Active comparator | Drug: Dutogliptin Tartrate, Drug: Filgrastim Injectable ProductTwice daily SC injections of 60 mg dutogliptin tartrate for 14 days in combination with 10 µg/kg filgrastim injectable product for 5 days |
| Placebo control | Placebo comparator | Drug: PlacebosTwice daily dutogliptin SC placebos for 14 days in combination with matching filgrastim SC placebos for 5 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Male or female born between 1933 and 2000.
- Body weight <96 kg (212 lb).
- Able to provide written informed consent, including signing and dating the informed consent form (ICF).
- Diagnosis of STEMI (defined as new ST-segment elevation at the J point of at least 2 continuous leads of >2 mm [0.2 mV] in men or >1.5 mm [0.1 mV] in women in leads V2 and V3 OR >1 mm in any other contiguous precordial leads or the limb leads [for both men and women]) with PCI (bare metal or drug-eluting stent) and Thrombolysis in Myocardial Infarction flow grade 2 or 3 occurring >2 hours and <24 hours after symptom onset.
- LVEF ≤45% obtained by cECHO performed within 36 hours post-stent placement.
Key exclusion criteria (31 listed)
- Previous MI prior to Screening.
- Complex peri/post-MI clinical course, including arrhythmias, cardiogenic shock, pulmonary edema requiring mechanical ventilation, or requirement for vasopressor medications.
- Significant pre-existing cardiomyopathy with known LVEF ≤45% or moderate to severe mitral or aortic valvular disease.
- Amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- Existing heart transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutogliptin TartrateAlso: dutogliptinActive treatment | Drug | Dutogliptin/filgrastim combination |
| Filgrastim Injectable ProductAlso: filgrastimActive treatment | Drug | Dutogliptin/filgrastim combination |
| PlacebosAlso: placeboplacebo control | Drug | Placebo control |
Primary outcome
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.
Time frame: 90 days
Assess the tolerability of a combination of dutogliptin and filgrastim
8 secondary outcomes
Cardiovascular efficacy LVEF
Time frame: 90 days
Cardiovascular efficacy LVESV
Time frame: 90 days
Cardiovascular efficacy LVEDV
Time frame: 90 days
Cardiovascular tissue damage reduction
Time frame: 90 days
Cardiovascular LFM
Time frame: 90 days
Cardiovascular motion
Time frame: 90 days
Pharmacokinetics (PK)
Time frame: 14 days
Pharmacodynamics (PD)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Recardio, Inc. HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Schenk, MD study chair
Recardio, Inc.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dutogliptin Tartrate and Filgrastim Injectable Product in people with Acute Myocardial Infarction and Acute Myocardial Ischemia, run by Recardio, Inc. at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Hungary, Poland, Austria, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.