Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

NCT01114438 | Completed Results

• 1 other identifier: 10-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.

Conditions

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (4)

• HbA1c (%) Measured at Week 52

  12 months

• Total Weight Change From Baseline to Week 52

  Total weight change at 12 months (kg) compared to baseline

  12 months

• Changes in Diabetic Medications at Treatment Completion Compared to Baseline

  number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)

  12 months

• Change From Baseline in SF 36v2 Quality of Life Assessment

  Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.

  Baseline, 12 months (explant), 6 months post explant (18 months post baseline)

Study Arms (1)

Device

EXPERIMENTAL

Device: EndoBarrier Gastrointestinal Liner

Interventions

EndoBarrier Gastrointestinal Liner DEVICE

EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.

Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects Age \> 18 years and ≤65 years - Male or Female
• Subjects with Type 2 Diabetes \> 1 and ≤ 10 years in duration
• Subjects with an Hb A1c level \> 7.5 and ≤ 10.0
• Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
• Subjects with a BMI \> 30 and\< 50
• Subjects willing to comply with study requirements
• Subjects who have signed an informed consent form
• Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.

You may not qualify if:

• Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)
• Subjects requiring insulin \>150 units per day
• Subjects with probable insulin production failure (fasting C Peptide serum \<1.0 ng/mL)
• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
• Subjects with or a history of iron deficiency and/or iron deficiency anemia
• Subjects with or a history of abnormalities of the GI tract
• Subjects with symptomatic gallstones or kidney stones at the time of screening
• Subjects with a known infection
• Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
• Subjects 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 study participation
• Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
• Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
• Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (3)

Imperial College/St. Mary's Hospital

London, United Kingdom

Location

Trafford General Hospital/NOSC

Manchester, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: GI Dynamics

kwoessner@gidynamics.com

781.357.3263

Study Officials

• Julian Teare, MD

  Imperial College/St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: April 29, 2010
• First Posted: May 3, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 24, 2017
• Results First Posted: February 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (3)