Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)
2. december 2016 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
325
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Mayo Clinic Arizona
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Little Rock Diagnostic Center (LRDC)
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California
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado/ Anschutz Health & Wellness Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60208
- Northwestern University
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40218
- Kentucky Research Group
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112-2699
- Tulane University Health Sciences Center
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Maryland
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Hyattsville, Maryland, Forenede Stater, 20782
- MedStar Health Research Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Minnesota
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University
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Montana
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic
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New York
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New York, New York, Forenede Stater, 10003
- Beth Israel Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, Forenede Stater, 97232
- Legacy Research Institute
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
- Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
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Texas
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Dallas, Texas, Forenede Stater, 75230
- Dallas Diabetes
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Dallas, Texas, Forenede Stater, 75390-7170
- UT Southwestern Medical Center
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Houston, Texas, Forenede Stater, 77030
- The Methodist Hospital Research Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
17 år til 61 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Device (EndoBarrier)
Device for glycemic control
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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 navne:
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Sham-komparator: Sham Procedure
sham procedure
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Endoscopic evaluation but no device placement
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Primary Efficacy Endpoint: Improvement in HbA1c
Tidsramme: Baseline and12 months
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Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
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Baseline and12 months
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Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
Tidsramme: Baseline and 12 Months
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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.
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Baseline and 12 Months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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LDL Change From Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Triglycerides Change From Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Fasting Glucose Change From Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Systolic BP Change From Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Diastolic BP Change From Baseline
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
Tidsramme: Baseline and 12 Months
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Baseline and 12 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Lee M Kaplan, MD, PhD, Massachusetts General Hospital
- Studieleder: Keith Gersin, MD, Carolinas Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2012
Primær færdiggørelse (Faktiske)
1. februar 2016
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
13. november 2012
Først indsendt, der opfyldte QC-kriterier
13. november 2012
Først opslået (Skøn)
16. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ja
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