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

Not Applicable

Completed

Conditions: Type II Diabetes

Interventions: Device: EndoBarrier
Behavioral: Diet + Lifestyle Counseling

Registration Number: NCT00985114

Lead Sponsor: Morphic Medical Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 77

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	EndoBarrier	EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.
Device	Diet + Lifestyle Counseling	EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.
Diet + Lifestyle counseling	Diet + Lifestyle Counseling	Multidisciplinary lifestyle and nutritional counseling for 12 months

Primary Outcome Measures

Name	Time	Method
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.	6 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Medisch Centrum Parkstad
🇳🇱
Heerlen, Netherlands
Ziekenhuis Rijnstate Arnhem
🇳🇱
Arnhem, Netherlands
University Hospital Maastricht
🇳🇱
Maastricht, Netherlands