Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

• ClinicalTrials.gov Identifier: NCT00985114
• Recruitment Status: Completed
• First Posted: September 28, 2009
• Results First Posted: October 3, 2016
• Last Update Posted: October 3, 2016
• Sponsor: GI Dynamics
• Information provided by (Responsible Party): GI Dynamics

Tracking Information

• First Submitted Date: September 25, 2009
• First Posted Date: September 28, 2009
• Results First Submitted Date: March 20, 2016
• Results First Posted Date: October 3, 2016
• Last Update Posted Date: October 3, 2016
• Study Start Date: October 2009
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 9, 2016): Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline. [ Time Frame: 6 months ]
• Original Primary Outcome Measures (submitted: September 25, 2009): Percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline. [ Time Frame: 6 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
• Official Title: An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.

This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.

The primary efficacy endpoint is:

• Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.

Secondary endpoints are:

• Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.
• Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.
• Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.
• Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
• Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.
• Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.

• Detailed Description: Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type II Diabetes

Intervention

• Device: EndoBarrier
  EndoBarrier implant
• Behavioral: Diet + Lifestyle Counseling
  Multidisciplinary lifestyle and nutritional counseling

Study Arms

• Experimental: Device
  EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.
  Interventions:

  • Device: EndoBarrier
  • Behavioral: Diet + Lifestyle Counseling
• Active Comparator: Diet + Lifestyle counseling
  Multidisciplinary lifestyle and nutritional counseling for 12 months
  Intervention: Behavioral: Diet + Lifestyle Counseling

Publications *

• de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Bouvy ND, Greve JW. Impact of Duodenal-Jejunal Exclusion on Satiety Hormones. Obes Surg. 2016 Mar;26(3):672-8. doi: 10.1007/s11695-015-1889-y.
• Koehestanie P, de Jonge C, Berends FJ, Janssen IM, Bouvy ND, Greve JW. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. 2014 Dec;260(6):984-92. doi: 10.1097/SLA.0000000000000794.
• de Jonge C, Rensen SS, Koek GH, Joosten MF, Buurman WA, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves plasma parameters of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1517-20. doi: 10.1016/j.cgh.2013.07.029. Epub 2013 Aug 3.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2016): 77
• Original Estimated Enrollment (submitted: September 25, 2009): 70
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age > 18 years and < 65 years
• Male or Female
• Subjects with Type 2 Diabetes who have been treated for ≤10 years
• BMI> 30 - < 50
• Subjects with an HbA1c level > 7.5 and ≤ 10.0%
• Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30)
• Patients willing to comply with study requirements
• Patients who have signed an informed consent form

Exclusion Criteria:

• Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin
• Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
• Subjects on insulin > 10 years
• Subjects requiring insulin > 70 units per day
• Subjects on pre-mixed insulin (ie. NovoMix 30)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00985114
• Other Study ID Numbers: 07-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

Plan Description

Yes

De-identified individual subject data is on file at the Sponsor

• Current Responsible Party: GI Dynamics
• Original Responsible Party: Jan Willem Greve, M.D., Ph.D., Atrium Ziekenhuis Heerlen
• Current Study Sponsor: GI Dynamics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jan Willem Greve, MD; University Hospital Masstricht

• PRS Account: GI Dynamics
• Verification Date: August 2016