Type 2 DiabetesENDONCT01728116

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

A study testing EndoBarrier in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 25 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type 2 Diabetes, Obesity
What is being tested?: EndoBarrier
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 325 participants
Where: 25 sitesUnited States
Study dates: Dec 2012to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 29Show fewer

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

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

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

Other trials in United States

About this study

Official title: 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

Read the detailed description

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.

Conditions: Type 2 Diabetes, Obesity
Being tested: EndoBarrier, Sham Procedure
Keywords: glycemic control, type 2 diabetes, device, obese
Medical subject headings: Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EndoBarrierDevice
Also called Duodenal-jejunal bypass liner (DJBL)
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
Sham ProcedureProcedure or surgery
Endoscopic evaluation but no device placement

Study groups in NCT01728116
Study group	Role	What they receive
Device (EndoBarrier)	Experimental	Device for glycemic control Receives: Device: EndoBarrier
Sham Procedure	Sham comparator	sham procedure Receives: Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Efficacy Endpoint: Improvement in HbA1c
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Measured: 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.
Measured: Baseline and 12 Months

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Feb 2016

First posted16 Nov 2012 (estimated)
Study startDec 2012
Primary completionFeb 2016
Study completionFeb 2016

Why it stopped: Higher than anticipated rate of Hepatic abscess (N=7)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 325 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728116
Sponsor's protocol ID: 09-1
Acronym: ENDO
Status last verified: Dec 2016
First submitted: 13 Nov 2012
Last updated: 1 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01728116
Acronym / sponsor ID: ENDO / 09-1
Conditions: Type 2 Diabetes, Obesity
Keywords: glycemic control, type 2 diabetes, device, obese
Study type: Interventional
Recruitment status: TerminatedReason stopped: Higher than anticipated rate of Hepatic abscess (N=7)
Enrolment: 325 participants (actual)
Lead sponsor: Morphic Medical Inc.Industry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 16 Nov 2012 (estimated)
Results: Posted 2 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Device (EndoBarrier)	Experimental	Device: EndoBarrierDevice for glycemic control
Sham Procedure	Sham comparator	Procedure: Sham Proceduresham procedure

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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%.

Key exclusion criteria (29 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EndoBarrierAlso: Duodenal-jejunal bypass liner (DJBL)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	Device	Device (EndoBarrier)
Sham ProcedureEndoscopic evaluation but no device placement	Procedure or surgery	Sham Procedure

Primary outcome

Primary Efficacy Endpoint: Improvement in HbA1c
Time frame: Baseline and12 months
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
Time frame: 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.

8 secondary outcomes

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

Results and safety

Results posted to the registry on 2 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EndoBarrier Group	213	52
Sham Control Group	107	60

Primary outcome: Primary Efficacy Endpoint: Improvement in HbA1c

Time frame: Baseline and12 months. Mean (Standard Deviation). Unit: Percentage of HbA1c

Measure	EndoBarrier Group n = 213	Sham Control Group n = 107
Value	-1.07 (1.5)	-0.31 (1.59)

Population analysed: All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.

Primary outcome: Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE

Time frame: Baseline and 12 Months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	EndoBarrier Group n = 161
Value	11.8 (7.8 to 17.7)

Population analysed: mITT without Imputation

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months for device subjects, 12 months for sham subjects. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EndoBarrier Group	53 of 212 (25%)	206 of 212 (97.2%)	Not reported
Sham Control Group	5 of 108 (4.6%)	96 of 108 (88.9%)	Not reported

Limitations and caveats (from the sponsor): The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
GI Dynamics websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Type 2 Diabetes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lee M Kaplan, MD, PhD study chair

Massachusetts General Hospital

Keith Gersin, MD study director

Carolinas Medical Center

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EndoBarrier in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint: Improvement in HbA1c (time frame: Baseline and12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.