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EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

Primary Purpose

Obesity, Type 2 Diabetes

Status

Terminated

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

EndoBarrier SANS

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Universiti Malaya Medical Centre, Jalan universiti

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

Subjects who receive the device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy as measured by Change in Body weight

Change in Body weight

Efficacy as measured by Percent excess weight loss

Percent excess weight loss

Efficacy as measured by Change in HbA1c (%)

Change in HbA1c (%)

Full Information

NCT ID

NCT02443753

First Posted

May 11, 2015

Last Updated

February 9, 2016

Sponsor

GI Dynamics

Collaborators

University of Malaya

1. Study Identification

Unique Protocol Identification Number

NCT02443753

Brief Title

EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

Official Title

A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GI Dynamics

Collaborators

University of Malaya

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Experimental

Arm Description

Subjects who receive the device

Intervention Type

Device

Intervention Name(s)

EndoBarrier SANS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.

Description

Safety will be evaluated as the incidence of AEs and SAEs/UADEs.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Efficacy as measured by Change in Body weight

Description

Change in Body weight

Time Frame

3 months

Title

Efficacy as measured by Percent excess weight loss

Description

Percent excess weight loss

Time Frame

3 months

Title

Efficacy as measured by Change in HbA1c (%)

Description

Change in HbA1c (%)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eng Hong Pok, MD

Organizational Affiliation

University of Malaya

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wah Kheong Chan, MD

Organizational Affiliation

University of Malaya

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universiti Malaya Medical Centre, Jalan universiti

City

Kuala Lumpur

ZIP/Postal Code

50603

Country

Malaysia

12. IPD Sharing Statement

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EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects

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