A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Morphic Medical Inc.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Assessment of Glycemic Control (HbA1c) Over Time
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects Age \> 18 years and ≤ 55 years
- •Male or Female
- •Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
- •Subjects with an HbA1C \> 7.5 and ≤ 10.0%
- •Subjects with a BMI \> 26 - \< 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 oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.
Exclusion Criteria
- •Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- •Subjects requiring insulin
- •Subjects with probable insulin production failure (fasting C Peptide serum \<1ng/mL)
- •Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
- •Subjects with a weight loss of \> 4.5 Kg (10 lbs) within the 12 Weeks of screening
- •Subjects requiring prescription anticoagulation therapy
- •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
Outcomes
Primary Outcomes
Assessment of Glycemic Control (HbA1c) Over Time
Time Frame: Baseline to 12 Months with device implanted
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Change in Anti-diabetes Medications
Time Frame: Baseline to 52 weeks
Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."
Secondary Outcomes
- Total Weight Change (kg) at Week 52 Compared to Baseline Weight(Baseline to 52 weeks)