Type 2 DiabetesNCT01114438

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

A study testing EndoBarrier Gastrointestinal Liner in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes, Obesity
What is being tested?: EndoBarrier Gastrointestinal Liner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 3 sitesUnited Kingdom
Study dates: Oct 2010to Jul 2013
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

Imperial College/St. Mary's Hospital
London
Trafford General Hospital/NOSC
Manchester
Southampton General Hospital
Southampton

Other trials in United Kingdom

About this study

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

Conditions: Type 2 Diabetes, Obesity
Being tested: EndoBarrier Gastrointestinal Liner
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.

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

Study groups in NCT01114438
Study group	Role	What they receive
Device	Experimental	Not described Receives: Device: EndoBarrier Gastrointestinal Liner

What is being measured

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

HbA1c (%) Measured at Week 52
Measured: 12 months
Total Weight Change From Baseline to Week 52
Total weight change at 12 months (kg) compared to baseline
Measured: 12 months
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)
Measured: 12 months
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.
Measured: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)

Timeline

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

Oct 2010Jul 2013

First posted3 May 2010 (estimated)
Study startOct 2010
Primary completionJan 2013
Study completionJul 2013

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01114438
Sponsor's protocol ID: 10-1
Status last verified: Apr 2017
First submitted: 29 Apr 2010
Last updated: 24 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual subject data is on file at the Sponsor

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 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
ClinicalTrials.gov ID: NCT01114438
Acronym / sponsor ID: 10-1
Conditions: Type 2 Diabetes, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Morphic Medical Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jan 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 3 May 2010 (estimated)
Results: Posted 20 Feb 2017

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Device	Experimental	Device: EndoBarrier Gastrointestinal Liner

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (17 listed)

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 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

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

Primary outcome

HbA1c (%) Measured at Week 52
Time frame: 12 months
Total Weight Change From Baseline to Week 52
Time frame: 12 months
Total weight change at 12 months (kg) compared to baseline
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
Time frame: 12 months
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
Change From Baseline in SF 36v2 Quality of Life Assessment
Time frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
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.

Results and safety

Results posted to the registry on 20 Feb 2017, 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 Gastrointestinal Liner	45	31

Primary outcome: HbA1c (%) Measured at Week 52

Time frame: 12 months. Median (Full Range). Unit: % glycated hemoglobin

Measure	EndoBarrier Liner Device n = 29
Value	7.3 (5.8 to 11.5)

Population analysed: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.

Primary outcome: Total Weight Change From Baseline to Week 52

Time frame: 12 months. Mean (Standard Deviation). Unit: kg

Measure	EndoBarrier Liner Device n = 29
Value	-12.1 (7.0)

Population analysed: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.

Primary outcome: Changes in Diabetic Medications at Treatment Completion Compared to Baseline

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Decrease in Glucose-Lowering Meds n = 45	Increase in Glucose-Lowering Meds at Week 52 n = 45	No Change in Glucose-Lowering Meds at Week 52 n = 45
Value	23	4	18

Population analysed: Analysis was conducted on subjects with a device

Primary outcome: Change From Baseline in SF 36v2 Quality of Life Assessment

Time frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline). Mean (Standard Deviation). Unit: units on a scale

Measure	Device at Month 12 (Explant) n = 35	Device at 6 Months Post-explant n = 25
PCS-Change from Baseline	1.0 (9.49)	1.0 (8.33)
MCS-Change from Baseline	3.0 (9.66)	-0.5 (14.12)

Population analysed: The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device	13 of 45 (28.9%)	40 of 45 (88.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual subject data is on file at the Sponsor

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.

Julian Teare, MD principal investigator

Imperial College/St. Mary's Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing EndoBarrier Gastrointestinal Liner in people with Type 2 Diabetes and Obesity, run by Morphic Medical Inc. at 3 sites in United Kingdom.

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 8 inclusion and 17 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: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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. 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 20 Feb 2017). 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?

HbA1c (%) Measured at Week 52 (time frame: 12 months). The study lists 4 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 NCT01114438.

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 24 Apr 2017.