Type 2 DiabetesNCT00973960
A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
An observational study of Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Chile.
Trial summary
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes. The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- Sep 2009to Dec 2010
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with Type 2 Diabetes
Who may be able to join
- Age > 18 years and < 55 years - Male or Female
- BMI > 30 BMI <60
- Subjects with an HbA1c > 7.5 and ≤ 10.0%
- Subjects with Type 2 diabetes who have been treated for ≤10 years
- Subjects on Metformin and/or Sulfonylurea
- History of failure with nonsurgical weight loss methods
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- Subjects willing to comply with trial requirements
- Subjects who have signed an informed consent form
- Women who are post-menopausal, surgically sterile or on oral contraceptives and who do not plan on becoming pregnant during the course of the trial.
Who cannot join
- Treatment represents an unreasonable risk to the subject
- Subjects on oral diabetic medications other than Metformin or Sulfonylurea
- Subjects on insulin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects with a past medical history of hypoglycemia
- Subjects with abnormal gastric emptying at baseline, defined as < 90% stomach emptied at 4 hours
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- Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
- Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
- Pregnant or have intention of becoming pregnant for the duration of the trial
- Unresolved alcohol or drug addiction
- Subjects receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
- Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Flow Restrictor or the function of the implant.
- Subjects with active and uncontrolled GERD
- Subjects with symptomatic kidney stones prior to implant
- Subjects with iron deficiency and/or iron deficiency anemia
- History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Subjects with symptomatic gallstones prior to implant
- Symptomatic coronary artery disease or pulmonary dysfunction
- Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
- History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
- Pancreatitis or other serious organic conditions
- Subjects requiring prescription anticoagulation therapy
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Participating in another ongoing investigational clinical trial
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial.
- Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Measured: 24 weeks
Secondary outcomes (1)
The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alex Escalona, MD, Principal investigator, Hospital Universidad Catolica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973960
- Sponsor's protocol ID
- 09-2
- Status last verified
- Aug 2011
- First submitted
- 6 Sep 2009
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT00973960
- Acronym / sponsor ID
- 09-2
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Morphic Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Sep 2009 (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.
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with Type 2 Diabetes
Key inclusion criteria (9 listed)
- Age > 18 years and < 55 years - Male or Female
- BMI > 30 BMI <60
- Subjects with an HbA1c > 7.5 and ≤ 10.0%
- Subjects with Type 2 diabetes who have been treated for ≤10 years
- Subjects on Metformin and/or Sulfonylurea
Key exclusion criteria (28 listed)
- Treatment represents an unreasonable risk to the subject
- Subjects on oral diabetic medications other than Metformin or Sulfonylurea
- Subjects on insulin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects with a past medical history of hypoglycemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Time frame: 24 weeks
1 secondary outcome
The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related).
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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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.
Alex Escalona, MD principal investigator
Hospital Universidad Catolica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Morphic Medical Inc. at 1 site in Chile.
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 28 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 8 Aug 2011. 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 Chile. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c. (time frame: 24 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 8 Aug 2011.