Status:
COMPLETED
Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Type II Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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, contro...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00985114
Start Date
October 1 2009
End Date
January 1 2013
Last Update
October 3 2016
Active Locations (3)
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1
Ziekenhuis Rijnstate Arnhem
Arnhem, Netherlands
2
Medisch Centrum Parkstad
Heerlen, Netherlands
3
University Hospital Maastricht
Maastricht, Netherlands