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

NCT02443753 | Terminated

• 1 other identifier: 15-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Efficacy as measured by Change in Body weight

  3 months

• Efficacy as measured by Percent excess weight loss

  3 months

• Efficacy as measured by Change in HbA1c (%)

  3 months

Study Arms (1)

Device

EXPERIMENTAL

Subjects who receive the device

Device: EndoBarrier SANS

Interventions

EndoBarrier SANS DEVICE

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.

Device

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphic Medical Inc.: lead
• University of Malaya: collaborator

Study Sites (1)

Universiti Malaya Medical Centre, Jalan universiti

Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eng Hong Pok, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Wah Kheong Chan, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

MY (1)