Type 2 DiabetesPhase 1/2NCT02709577
A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
A Phase 1/2 study testing EndoBarrier Gastrointestinal Liner in people with Type 2 Diabetes, run by Morphic Medical Inc..
Trial summary
The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control 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 Gastrointestinal Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2009
- Phase
- Phase 1/2
- 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
- Age > 18 years and < 55 years - Male or Female
- Patients with type 2 diabetes, treated for 10 years or less
- HbA1c level ≥ 7.0 and ≤ 10.0%
- Fasting glucose ≤ 240 mg/dl
- Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination
- BMI > 30 and <50
Show all 9Show fewer
- Patients willing to comply with study requirements
- Patients who have signed an informed consent form
- Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study.
Who cannot join
- Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones
- Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis
- Patients requiring insulin
- Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml)
- Patients with a weight loss of > 10 lbs within the three months of screening
- Patients requiring prescription anticoagulation therapy
Show all 22Show fewer
- Patients with iron deficiency and iron deficiency anemia
- Patients with a history of abnormal pathologies of the GI tract
- Patients with known gallstones or kidney stones prior to implant
- 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
- Pregnant or has the intention of becoming pregnant in the next 12 months
- Patients with a history of active kidney stones
- 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
- Previous GI surgery that could affect the ability to place the sleeve or the function of the implant
- Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
- Patients receiving weight loss medications such as Meridia and Xenical
- Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder
- Patients with Gastrointestinal Reflux Disease (GERD)
- Participating in another ongoing investigational clinical trial
- Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)
About this study
Official title: A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes
The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
Read the detailed description
The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks.
Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.
- Conditions
- Type 2 Diabetes
- Being tested
- EndoBarrier Gastrointestinal Liner, Sham: endoscopy and standard of care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoBarrier Gastrointestinal LinerDevice
Also called GI Sleeve
The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
Sham: endoscopy and standard of careOther
Also called Control
Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
| Study group | Role | What they receive |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | Experimental | Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints. Receives: Device: EndoBarrier Gastrointestinal Liner |
| Sham: endoscopy and standard of care | Experimental | Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints. Receives: Other: Sham: endoscopy and standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Values From Baseline Measurement
Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.
Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
Measured: Baseline to 24 weeks or 52 weeks
Secondary outcomes (1)
Absolute Weight Change
Measured: 24 weeks or 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Dipreca
- Responsible party
- Sponsor
- Investigators
- Leonardo Rodriguez Grunert, MD, Principal investigator, Hospital Dipreca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709577
- Sponsor's protocol ID
- 06-5
- Status last verified
- Nov 2016
- First submitted
- 11 Mar 2016
- Last updated
- 28 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02709577
- Acronym / sponsor ID
- 06-5
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Dipreca
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 28 Dec 2016
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 the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
Detailed description
The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks.
Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoBarrier Gastrointestinal Liner | Experimental | Device: EndoBarrier Gastrointestinal LinerSubjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints. |
| Sham: endoscopy and standard of care | Experimental | Other: Sham: endoscopy and standard of careSubjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age > 18 years and < 55 years - Male or Female
- Patients with type 2 diabetes, treated for 10 years or less
- HbA1c level ≥ 7.0 and ≤ 10.0%
- Fasting glucose ≤ 240 mg/dl
- Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination
Key exclusion criteria (22 listed)
- Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones
- Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis
- Patients requiring insulin
- Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml)
- Patients with a weight loss of > 10 lbs within the three months 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 Gastrointestinal LinerAlso: GI SleeveThe EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum. | Device | EndoBarrier Gastrointestinal Liner |
| Sham: endoscopy and standard of careAlso: ControlSham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes | Other | Sham: endoscopy and standard of care |
Primary outcome
Change in HbA1c Values From Baseline Measurement
Time frame: Baseline to 24 weeks or 52 weeks
Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
1 secondary outcome
Absolute Weight Change
Time frame: 24 weeks or 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Leonardo Rodriguez Grunert, MD principal investigator
Hospital Dipreca
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EndoBarrier Gastrointestinal Liner in people with Type 2 Diabetes, run by Morphic Medical Inc..
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 9 inclusion and 22 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 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?
Change in HbA1c Values From Baseline Measurement (time frame: Baseline to 24 weeks or 52 weeks). 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 28 Dec 2016.