Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)
2 december 2016 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
325
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259
- Mayo Clinic Arizona
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Little Rock Diagnostic Center (LRDC)
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California
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Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
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Stanford, California, Förenta staterna, 94305
- Stanford University School of Medicine
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado/ Anschutz Health & Wellness Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30303
- Emory University
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Illinois
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Chicago, Illinois, Förenta staterna, 60208
- Northwestern University
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40218
- Kentucky Research Group
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane University Health Sciences Center
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Maryland
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Hyattsville, Maryland, Förenta staterna, 20782
- Medstar Health Research Institute
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Minnesota
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Missouri
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St Louis, Missouri, Förenta staterna, 63110
- Washington University
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Montana
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic
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New York
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New York, New York, Förenta staterna, 10003
- Beth Israel Medical Center
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, Förenta staterna, 97232
- Legacy Research Institute
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37909
- Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
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Texas
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Dallas, Texas, Förenta staterna, 75230
- Dallas Diabetes
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Dallas, Texas, Förenta staterna, 75390-7170
- UT Southwestern Medical Center
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Houston, Texas, Förenta staterna, 77030
- The Methodist Hospital Research Institute
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
17 år till 61 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
Andra namn:
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Sham Comparator: Sham Procedure
sham procedure
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Endoscopic evaluation but no device placement
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Primary Efficacy Endpoint: Improvement in HbA1c
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
Tidsram: 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
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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LDL Change From Baseline
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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Triglycerides Change From Baseline
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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Fasting Glucose Change From Baseline
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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Systolic BP Change From Baseline
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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Diastolic BP Change From Baseline
Tidsram: 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
Tidsram: Baseline and 12 Months
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Baseline and 12 Months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Lee M Kaplan, MD, PhD, Massachusetts General Hospital
- Studierektor: Keith Gersin, MD, Carolinas Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2012
Primärt slutförande (Faktisk)
1 februari 2016
Avslutad studie (Faktisk)
1 februari 2016
Studieregistreringsdatum
Först inskickad
13 november 2012
Först inskickad som uppfyllde QC-kriterierna
13 november 2012
Första postat (Uppskatta)
16 november 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
1 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-1
Plan för individuella deltagardata (IPD)
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Ja
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