Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)

2. desember 2016 oppdatert av: GI Dynamics

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

Studietype

Intervensjonell

Registrering (Faktiske)

325

Fase

  • Ikke aktuelt

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, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Little Rock Diagnostic Center (LRDC)
    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Medical Center
      • Stanford, California, Forente stater, 94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado/ Anschutz Health & Wellness Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30303
        • Emory University
    • Illinois
      • Chicago, Illinois, Forente stater, 60208
        • Northwestern University
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40218
        • Kentucky Research Group
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112-2699
        • Tulane University Health Sciences Center
    • Maryland
      • Hyattsville, Maryland, Forente stater, 20782
        • Medstar Health Research Institute
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic Minnesota
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic
    • New York
      • New York, New York, Forente stater, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, Forente stater, 97232
        • Legacy Research Institute
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Dallas Diabetes
      • Dallas, Texas, Forente stater, 75390-7170
        • UT Southwestern Medical Center
      • Houston, Texas, Forente stater, 77030
        • The Methodist Hospital Research Institute

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

17 år til 61 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Males/females aged ≥ 21 years and ≤ 65 years
  • Diagnosis of Type 2 Diabetes for ≤ 20 years
  • Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)
  • Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD)
  • Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.
  • Subjects willing to comply with study requirements
  • Subjects who have signed an informed consent form

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  • C-peptide < 1.0 ng/mL
  • Triglyceride level > 400 mg/dL
  • Vitamin D deficiency (<20 ng/mL)
  • Male subjects with serum Creatinine >1.5 mg/dl or female subjects with Creatinine >1.4 mg/dL
  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  • Height < 5 feet (152.4 cm)
  • Current alcohol or drug addiction
  • Symptomatic kidney stones or gallstones within 6 months prior to randomization
  • Chronic pancreatitis or acute pancreatitis within 12 months of randomization
  • Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
  • Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
  • Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump Inhibitor (PPI)
  • Thyroid disease unless controlled with medication
  • Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure
  • Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure
  • Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure
  • Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening
  • Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers
  • Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics
  • Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
  • Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner
  • Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization
  • Any condition or major illness that places the subject at undue risk by participating in the study
  • Poor dentition not allowing complete chewing of food
  • Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted)
  • Residing in a location without ready access to study site medical resources
  • Documented weight loss of >10 pounds anytime during the 3 months preceding randomization
  • Positive stool guaiac at time of screening

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Device (EndoBarrier)
Device for glycemic control
Enhet: EndoBarrier
Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
Andre navn:
  • Duodenal-jejunal bypass liner (DJBL)
Sham-komparator: Sham Procedure
sham procedure
Fremgangsmåte: Sham Procedure
Endoscopic evaluation but no device placement

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Efficacy Endpoint: Improvement in HbA1c
Tidsramme: Baseline and12 months
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Baseline and12 months
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
Tidsramme: Baseline and 12 Months
Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
Baseline and 12 Months

Sekundære resultatmål

Resultatmål
Tidsramme
Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
LDL Change From Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Triglycerides Change From Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Fasting Glucose Change From Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Systolic BP Change From Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Diastolic BP Change From Baseline
Tidsramme: Baseline and 12 Months
Baseline and 12 Months
Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
Tidsramme: Baseline and 12 Months
Baseline and 12 Months

Samarbeidspartnere og etterforskere

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

Sponsor

GI Dynamics

Etterforskere

  • Studiestol: Lee M Kaplan, MD, PhD, Massachusetts General Hospital
  • Studieleder: Keith Gersin, MD, Carolinas Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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. desember 2012

Primær fullføring (Faktiske)

1. februar 2016

Studiet fullført (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først innsendt

13. november 2012

Først innsendt som oppfylte QC-kriteriene

13. november 2012

Først lagt ut (Anslag)

16. november 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 09-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere