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

NCT01728116 | Terminated Results DMC

• 1 other identifier: 09-1
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Type 2 Diabetes; Obesity

Keywords

glycemic control, type 2 diabetes, device, obese

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Improvement in HbA1c

  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

  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

Secondary Outcomes (8)

• Assessment of Total Cholesterol Change at 12 Months Compared to Baseline

  Baseline and 12 Months

• Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months

  Baseline and 12 Months

• LDL Change From Baseline

  Baseline and 12 Months

• Triglycerides Change From Baseline

  Baseline and 12 Months

• Fasting Glucose Change From Baseline

  Baseline and 12 Months

Study Arms (2)

Device (EndoBarrier)

EXPERIMENTAL

Device for glycemic control

Device: EndoBarrier

Sham Procedure

SHAM COMPARATOR

sham procedure

Procedure: Sham Procedure

Interventions

EndoBarrier DEVICE

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

Also known as: Duodenal-jejunal bypass liner (DJBL)

Device (EndoBarrier)

Sham Procedure PROCEDURE

Endoscopic evaluation but no device placement

Sham Procedure

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (25)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Little Rock Diagnostic Center (LRDC)

Little Rock, Arkansas, 72205, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Colorado/ Anschutz Health & Wellness Center

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Northwestern University

Chicago, Illinois, 60208, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112-2699, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Legacy Research Institute

Portland, Oregon, 97232, United States

Location

Endocrinology Consultants of East Tennessee & Gastrointestinal Associates

Knoxville, Tennessee, 37909, United States

Location

Dallas Diabetes

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-7170, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Related Links

• GI Dynamics website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).

Results Point of Contact

• Title: Brian Callahan
• Organization: GI Dynamics, Inc

bcallahan@gidynamics.com

781.357.3302

Study Officials

• Lee M Kaplan, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

• Keith Gersin, MD

  Carolinas Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 1, 2017
• Results First Posted: December 2, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (25)