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

NCT00985114 | Completed Results DMC

• 1 other identifier: 07-1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 3

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.

Conditions

Type II Diabetes

Keywords

Type II Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.

  6 months

Study Arms (2)

Device

EXPERIMENTAL

EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.

Device: EndoBarrier; Behavioral: Diet + Lifestyle Counseling

Diet + Lifestyle counseling

ACTIVE COMPARATOR

Multidisciplinary lifestyle and nutritional counseling for 12 months

Behavioral: Diet + Lifestyle Counseling

Interventions

EndoBarrier DEVICE

EndoBarrier implant

Device

Diet + Lifestyle Counseling BEHAVIORAL

Multidisciplinary lifestyle and nutritional counseling

Device; Diet + Lifestyle counseling

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Morphic Medical Inc.: lead

Study Sites (3)

Ziekenhuis Rijnstate Arnhem

Arnhem, Netherlands

Location

Medisch Centrum Parkstad

Heerlen, Netherlands

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 26446491 DERIVED

• 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.

  PMID: 25072436 DERIVED

• 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.

  PMID: 23920034 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Diet

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: GI Dynamics, Inc.

kwoessner@gidynamics.com

781.357.3263

Study Officials

• Jan Willem Greve, MD

  University Hospital Masstricht

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-08

Locations

NL (3)