ObesityNCT02443753
EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
A study testing EndoBarrier SANS in people with Obesity and Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Malaysia.
Trial summary
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- EndoBarrier SANS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 21 years and < 65 years - male or female
- Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
- Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
- Glycemic state: HbA1c at screening 7.0-10.0%.
- History of failure with non-surgical weight loss methods
- Subjects willing to comply with study requirements
- Subjects who have signed an informed consent form
Who cannot join
- Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)
- Subjects requiring anticoagulation therapy
- Subjects with iron deficiency and iron deficiency anemia
- Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
- Treatment represents an unreasonable risk to the subject
- Known history of acute or chronic pancreatitis
Show all 27Show fewer
- Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
- Symptomatic coronary artery disease or pulmonary dysfunction
- Subjects with known symptomatic biliary disease
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- Pregnant or has the intention of becoming pregnant in the next 6 months
- Unresolved alcohol or drug addiction
- HIV positive subjects
- Subjects with hepatitis B or C
- Currently taking the following medications within 30 days of implant:
- systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat
- Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
- Previous GI surgery that could affect the ability to place the liner or the function of the implant.
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
- Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Unable to tolerate proton pump inhibitors
- Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
- Positive stool guaiac at time of screening
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Malaya Medical Centre, Jalan universiti
Kuala Lumpur, 50603
About this study
Official title: A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.
Read the detailed description
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- EndoBarrier SANS
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrier SANSDevice
Eligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months. The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Subjects who receive the device Receives: Device: EndoBarrier SANS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
Measured: 3 months
Secondary outcomes (3)
Efficacy as measured by Change in Body weight
Change in Body weight
Measured: 3 months
Efficacy as measured by Percent excess weight loss
Percent excess weight loss
Measured: 3 months
Efficacy as measured by Change in HbA1c (%)
Change in HbA1c (%)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Eng Hong Pok, MD, Principal investigator, University of MalayaWah Kheong Chan, MD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443753
- Sponsor's protocol ID
- 15-1
- Status last verified
- Feb 2016
- First submitted
- 11 May 2015
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT02443753
- Acronym / sponsor ID
- 15-1
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Malaya
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.
Detailed description
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.
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 SANSSubjects who receive the device |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 21 years and < 65 years - male or female
- Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
- Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
- Glycemic state: HbA1c at screening 7.0-10.0%.
- History of failure with non-surgical weight loss methods
Key exclusion criteria (27 listed)
- Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)
- Subjects requiring anticoagulation therapy
- Subjects with iron deficiency and iron deficiency anemia
- Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
- Treatment represents an unreasonable risk to the subject
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 SANSEligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months. The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery. | Device | Device |
Primary outcome
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
Time frame: 3 months
Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
3 secondary outcomes
Efficacy as measured by Change in Body weight
Time frame: 3 months
Efficacy as measured by Percent excess weight loss
Time frame: 3 months
Efficacy as measured by Change in HbA1c (%)
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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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.
Eng Hong Pok, MD principal investigator
University of Malaya
Wah Kheong Chan, MD principal investigator
University of Malaya
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 SANS in people with Obesity and Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Malaysia.
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 27 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 10 Feb 2016. 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 Malaysia. 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?
The study was stopped early. Results are not available in the source record.
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?
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2016.