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Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery (MAPSS)

7. mai 2015 oppdatert av: Duke University

Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35211
        • Cardiology, PC
      • Birmingham, Alabama, Forente stater, 35243
        • Cardio-Thoracic Surgeons PC
      • Huntsville, Alabama, Forente stater, 35801
        • Heart Center Research, LLC
    • Arkansas
      • Fort Smith, Arkansas, Forente stater, 72901
        • Sparks Regional Medical Center
      • Little Rock, Arkansas, Forente stater, 72205
        • Arkansas Cardiology, PA
    • California
      • Palo Alto, California, Forente stater, 94304
        • Stanford University Medical Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • Emory University Hospital Midtown
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center (DUMC)
    • Virginia
      • Richmond, Virginia, Forente stater, 23225
        • Chippenham Medical Center
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • Charleston Area Medical Center (CAMC)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.

    • Stable doses of oral antihyperglycemic agents for at least 2 months
    • Stable dose of chronic insulin therapy for at least 2 months
    • HbA1c documented within 3 months before study enrollment
  • Planned first elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria:

  • Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
  • Receiving incretin therapy or having received incretin therapy within the previous 2 months
  • Type 1 DM or a history of ketoacidosis
  • Women who are pregnant or breastfeeding
  • Known end-stage Kidney disease
  • Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
  • Clinically apparent liver disease
  • History of pancreatitis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Saxagliptin
Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Legemiddel: Saxagliptin
one 5-mg saxagliptin tablet daily
Andre navn:
  • Onglyza
Placebo komparator: Placebo
Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Legemiddel: Placebo
5mg placebo tablet daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Troponin I (TnI) Area Under the Curve (AUC)
Tidsramme: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
High Sensitive Troponin-I (hsTnT) Area Under the Curve
Tidsramme: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve
Tidsramme: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Number of Major Adverse Cardiac Events (MACE)
Tidsramme: Baseline to end of study (Approximately 35-37 days)
Death, myocardial infarction (MI), or New congestive heart failure (CHF)
Baseline to end of study (Approximately 35-37 days)
Duration of Inotropic Support
Tidsramme: CABG surg until hosp discharge (Approximately 5 days)
CABG surg until hosp discharge (Approximately 5 days)
Number of Participants Who Had an Episode of Hypoglycemia
Tidsramme: baseline to end of study (Approximately 35-37 days)
baseline to end of study (Approximately 35-37 days)
Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support
Tidsramme: CABG to hospital discharge (Approximately 5 days)
CABG to hospital discharge (Approximately 5 days)
Need for Antiarrhythmic Therapy
Tidsramme: CABG surg to hospital discharge Approximately 5 days
CABG surg to hospital discharge Approximately 5 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Duke University

Etterforskere

  • Hovedetterforsker: L. Kristin Newby, M.D., MHS, Duke University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2013

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

4. januar 2013

Først innsendt som oppfylte QC-kriteriene

8. januar 2013

Først lagt ut (Anslag)

10. januar 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. mai 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2015

Sist bekreftet

1. april 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00041744

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