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CompletedNCT01114438Updated Apr 24, 2017Results posted

Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

An interventional study of EndoBarrier Gastrointestinal Liner in Type 2 Diabetes and Obesity, sponsored by Morphic Medical Inc.. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Morphic Medical Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.

Read the detailed description

Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality

02

Conditions studied

  • Type 2 Diabetes
  • Obesity
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Morphic Medical Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects Age > 18 years and ≤65 years - Male or Female
  • Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
  • Subjects with an Hb A1c level > 7.5 and ≤ 10.0
  • Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
  • Subjects with a BMI > 30 and\< 50
  • Subjects willing to comply with study requirements
  • Subjects who have signed an informed consent form
  • Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.

Exclusion criteria

Exclusion Criteria:

  • Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)

  • Subjects requiring insulin >150 units per day

    • Subjects with probable insulin production failure (fasting C Peptide serum \<1.0 ng/mL)
  • Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
  • Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
  • Subjects with or a history of iron deficiency and/or iron deficiency anemia
  • Subjects with or a history of abnormalities of the GI tract
  • Subjects with symptomatic gallstones or kidney stones at the time of screening
  • Subjects with a known infection
  • Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  • Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical study participation
  • Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
  • Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
  • Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)
  • Subjects with severe liver or kidney failure (serum creatinine >180mmol/l)
  • Subjects with poor dentition who can not adequately chew their food
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Device

    Device: EndoBarrier Gastrointestinal Liner

Interventions

  • DeviceEndoBarrier Gastrointestinal Liner

    EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.

06

What researchers measure

Primary outcomes

  1. HbA1c (%) Measured at Week 52

    Time frame: 12 months

  2. Total Weight Change From Baseline to Week 52

    Total weight change at 12 months (kg) compared to baseline

    Time frame: 12 months

  3. Changes in Diabetic Medications at Treatment Completion Compared to Baseline

    number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)

    Time frame: 12 months

  4. Change From Baseline in SF 36v2 Quality of Life Assessment

    Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.

    Time frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)

07

Results

Posted Feb 20, 2017

Participant flow

Participant flow — Overall Study
MilestoneEndoBarrier Gastrointestinal Liner
Started45
Completed31
Not completed14
Withdrew: Adverse event10
Withdrew: Concomitant medication1
Withdrew: Physician decision1
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryHbA1c (%) Measured at Week 52
Time frame:
12 months
Reported as:
Median · % glycated hemoglobin
HbA1c (%) Measured at Week 52
% glycated hemoglobinEndoBarrier Liner Device
HbA1c (%) Measured at Week 527.3 (5.8 to 11.5)
PrimaryTotal Weight Change From Baseline to Week 52

Total weight change at 12 months (kg) compared to baseline

Time frame:
12 months
Reported as:
Mean · kg
Total Weight Change From Baseline to Week 52
kgEndoBarrier Liner Device
Total Weight Change From Baseline to Week 52-12.1 ± 7.0
PrimaryChanges in Diabetic Medications at Treatment Completion Compared to Baseline

number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)

Time frame:
12 months
Reported as:
Count of participants · Participants
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
ParticipantsDecrease in Glucose-Lowering MedsIncrease in Glucose-Lowering Meds at Week 52No Change in Glucose-Lowering Meds at Week 52
Changes in Diabetic Medications at Treatment Completion Compared to Baseline23418
PrimaryChange From Baseline in SF 36v2 Quality of Life Assessment

Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.

Time frame:
Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
Reported as:
Mean · units on a scale
Change From Baseline in SF 36v2 Quality of Life Assessment
units on a scaleDevice at Month 12 (Explant)Device at 6 Months Post-explant
PCS-Change from Baseline1.0 ± 9.491.0 ± 8.33
MCS-Change from Baseline3.0 ± 9.66-0.5 ± 14.12

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Device—13/45 (28.9%)40/45 (88.9%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventDevice
Abdominal pain upperGastrointestinal disorders3/45
Atrial FlutterCardiac disorders1/45
Myocardial infarctionCardiac disorders1/45
Abdominal pain lowerGastrointestinal disorders1/45
Abdominal painGastrointestinal disorders1/45
Chest painGeneral disorders1/45
Urinary tract infectionInfections and infestations1/45
GoutMetabolism and nutrition disorders1/45
Musculoskeletal painMusculoskeletal and connective tissue disorders1/45
Cerebrovascular accidentNervous system disorders1/45
Most frequent other events
Showing 10 of 25
Most frequent other events
EventDevice
Abdominal pain upperGastrointestinal disorders18/45
Vitamin D DeficiencyMetabolism and nutrition disorders14/45
Back painMusculoskeletal and connective tissue disorders10/45
DiarrheaGastrointestinal disorders9/45
NauseaGastrointestinal disorders8/45
VomitingGastrointestinal disorders8/45
Procedural nauseaInjury, poisoning and procedural complications8/45
Abdominal discomfortGastrointestinal disorders7/45
Abdominal painGastrointestinal disorders7/45
ConstipationGastrointestinal disorders6/45

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)EndoBarrier Gastrointestinal Liner
<=18 years0
Between 18 and 65 years45
>=65 years0
Age, Continuous
Age, Continuous(years)EndoBarrier Gastrointestinal Liner
Mean49.9 ± 7.97
Sex: Female, Male
Sex: Female, Male(Participants)EndoBarrier Gastrointestinal Liner
Female23
Male22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EndoBarrier Gastrointestinal Liner
Hispanic or Latino0
Not Hispanic or Latino0
Unknown or Not Reported45
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EndoBarrier Gastrointestinal Liner
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported45
Region of Enrollment
Region of Enrollment(participants)EndoBarrier Gastrointestinal Liner
United Kingdom45
Weight (kg)
Weight (kg)(kg)EndoBarrier Gastrointestinal Liner
Mean115 ± 21.02
BMI
BMI(kg/m2)EndoBarrier Gastrointestinal Liner
Mean40.0 ± 5.79

3 further baseline measures are reported on the registry.

08

Study locations

3 sites
  • Imperial College/St. Mary's Hospital
    London, United Kingdom
  • Trafford General Hospital/NOSC
    Manchester, United Kingdom
  • Southampton General Hospital
    Southampton, United Kingdom
09

References and documents

Individual participant data

Plan to share: Yes — De-identified individual subject data is on file at the Sponsor

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01114438
Lead sponsor
Morphic Medical Inc.
Responsible party
Sponsor
First posted
May 3, 2010
Start date
Oct 2010
Primary completion
Jan 2013
Completion
Jul 2013
Results posted
Feb 20, 2017
Last update
Apr 24, 2017

Study contacts

Julian Teare, MD
principal investigator · Imperial College/St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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