Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

A study testing EndoBarrier Liner in people with Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Brazil.

Completed

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

Trial summary

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: EndoBarrier Liner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteBrazil
Study dates: Jun 2010to Nov 2012
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects Age > 18 years and ≤ 55 years
Male or Female
Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
Subjects with an HbA1C > 7.5 and ≤ 10.0%
Subjects with a BMI > 26 - < 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 oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.

Who cannot join

Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
Subjects requiring insulin
Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL)
Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
Subjects requiring prescription anticoagulation therapy

Show all 21Show fewer

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 trial participation
Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
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 GERD
Subjects with a known history of substance abuse
Subjects participating in another ongoing investigational clinical trial
Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Alemão Oswaldo Cruz
São Paulo, CEP 01323-903

Other trials in Brazil

About this study

Official title: A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: EndoBarrier Liner
Keywords: Diabetes, Weight Loss, GI Dynamics, EndoBarrier
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Weight Loss

What participants receive

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

EndoBarrier LinerDevice
Also called EndoBarrier Gastrointestial Liner, GI Sleeve
52 week treatment of EnoBarrier Liner

Study groups in NCT00986349
Study group	Role	What they receive
Diabetes	Experimental	Single Arm Receives: Device: EndoBarrier Liner

What is being measured

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

Assessment of Glycemic Control (HbA1c) Over Time
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Measured: Baseline to 12 Months with device implanted
Change in Anti-diabetes Medications
Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."
Measured: Baseline to 52 weeks

Secondary outcomes (1)

Total Weight Change (kg) at Week 52 Compared to Baseline Weight
Measured: Baseline to 52 weeks

Timeline

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

Jun 2010Nov 2012

First posted29 Sep 2009 (estimated)
Study startJun 2010
Primary completionNov 2011
Study completionNov 2012

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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986349
Sponsor's protocol ID: 08-2
Status last verified: Jan 2017
First submitted: 27 Sep 2009
Last updated: 17 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient 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 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes
ClinicalTrials.gov ID: NCT00986349
Acronym / sponsor ID: 08-2
Conditions: Type 2 Diabetes
Keywords: Diabetes, Weight Loss, GI Dynamics, EndoBarrier
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Morphic Medical Inc.Industry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2012 (actual)
First posted: 29 Sep 2009 (estimated)
Results: Posted 2 Jan 2017

Clinical summary

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

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Study design

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

Arm	Type	Receives
Diabetes	Experimental	Device: EndoBarrier LinerSingle Arm

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subjects Age > 18 years and ≤ 55 years
Male or Female
Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
Subjects with an HbA1C > 7.5 and ≤ 10.0%
Subjects with a BMI > 26 - < 50

Key exclusion criteria (21 listed)

Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
Subjects requiring insulin
Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL)
Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening

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 LinerAlso: EndoBarrier Gastrointestial Liner, GI Sleeve52 week treatment of EnoBarrier Liner	Device	Diabetes

Primary outcome

Assessment of Glycemic Control (HbA1c) Over Time
Time frame: Baseline to 12 Months with device implanted
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Change in Anti-diabetes Medications
Time frame: Baseline to 52 weeks
Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."

1 secondary outcome

Total Weight Change (kg) at Week 52 Compared to Baseline Weight
Time frame: Baseline to 52 weeks

Results and safety

Results posted to the registry on 2 Jan 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 Liner Device	23	16

Primary outcome: Assessment of Glycemic Control (HbA1c) Over Time

Time frame: Baseline to 12 Months with device implanted. Median (Full Range). Unit: HbA1c %

Measure	EndoBarrier Liner Device at Baseline n = 20	EndoBarrier Liner Device at 3 Months n = 19	EndoBarrier Liner Device % at 6 Months n = 19	EndoBarrier Liner Device % at 9 Months n = 17	EndoBarrier Liner Device % at 52 Weeks n = 16
Value	8.7 (7.4 to 10.2)	6.7 (5.7 to 9.4)	6.9 (5.8 to 8.9)	6.9 (5.9 to 9.3)	6.8 (5.9 to 11.0)

Population analysed: 20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE

Primary outcome: Change in Anti-diabetes Medications

Time frame: Baseline to 52 weeks. Count of participants. Unit: Participants

Measure	Increase in Glucose-Lowering Meds at Week 52 n = 16	Decrease in Glucose-Lowering Meds n = 16	No Change in Glucose-Lowering Meds at Week 52 n = 16
Value	9	0	7

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EndoBarrier Liner Device	0 of 23 (0%)	22 of 23 (95.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual patient data is on file at the Sponsor

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have 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.

Ricardo Cohen, MD principal investigator

Hospital Alemão Oswaldo Cruz

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

Questions about this trial

What is this clinical trial studying?

A study testing EndoBarrier Liner in people with Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Brazil.

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 21 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 17 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 1 site in Brazil. 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 2 Jan 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?

Assessment of Glycemic Control (HbA1c) Over Time (time frame: Baseline to 12 Months with device implanted). 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 NCT00986349.

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 17 Feb 2017.