An Open-Label Extension to Protocol 09-1, Efficacy and Safety Study of the EndoBarrier® Gastrointestinal Liner System

NCT02293720 | Withdrawn DMC

• 1 other identifier: 09-1E
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A multi-center, single-arm, open-label study to evaluate the safety and effectiveness of the EndoBarrier Gastrointestinal Liner System liner on glycemic control in control subjects from study #09-1 who are not treatment failures and have completed 12 months of the study.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Mean change in HbA1c value from baseline to 12 months

  Changes in HbA1c from baseline to 12 month

  52 weeks

• Measure the incidence of device related serious adverse events requiring an early removal

  Demonstrated to be less than or equal to 15%

  52 weeks

Study Arms (1)

EndoBarrier Device

EXPERIMENTAL

Subjects who participated in the control arm of study #09-1 who are not treatment failures and have completed 12 months of the study. These subjects will have the EndoBarrier device implanted for 12 months.

Device: EndoBarrier

Interventions

EndoBarrier DEVICE

The EndoBarrier is indicated as an adjunct to diet and exercise to achieve weight loss and improve glycemic control in obese adults with type 2 diabetes whose anti-diabetes medications have not achieved adequate glycemic control.

EndoBarrier Device

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Control subjects from study # 09-1 who are not treatment failures and have completed 12 months of the study
• Age ≥21 years and ≤ 65 years
• Have signed an informed consent form within 30 days of week 52 visit in study #09-1.
• HbA1c ≥ 7.5% and ≤ 10%
• Stable (s) doses (up to 2) of anti -diabetes medication(s) for a minimum of 3 months prior to enrollment with at least one at minimum required dose as outlined below:
• MET (≥1500 mg/day) OR
• SU (based on doses specified below) Generic Name (brand name) minimum required dose
• Glimepiride (Amaryl) 4 (mg/day) Glipizide (Glucotrol) 20 (mg/day) Glipizide (Glucotrol XL) 10 (mg/day) Glyburide (Micronas, Diabeta) 10 (mg/day) Micronized Glyburide (Glynase) 6 (mg/day) Chlorpropamide (Diabinese) 350 (mg/day) Tolazamide (Tolinase 500 (mg/day) Tolbutamide (Orinase) 1500 (mg/day) OR
• DPP-4i (based on doses specified below) Generic Name (brand name) minimum required dose Sitagliptin (Januvia®) 50 (mg/day) Saxagliptin (Onglyza®) 2.5 (mg/day) Linagliptin (Tradjenta ®) 5 (mg/day) Alogliptin (Nesina®) 12.5 (mg/day)
• TZD (based on doses specified below) Generic Name (brand name) minimum required dose Rosiglitazone (Avandia®) 4 (mg/day) Pioglitazone (Actos®) 30 (mg/day)
• BMI ≥ 30 and ≤ 55
• Willing to comply with study requirements
• Documented negative pregnancy test in women of childbearing potential
• Women of childbearing potential not intending to become pregnant for the duration of their trial participation

You may not qualify if:

• Any change from the subject's previous health status from assessment for eligibility in pivotal trial phase (such as a new condition or major illness) that places the subject at undue risk by participating in the study
• C-peptide \< 1.0 ng/mL
• Triglyceride level \> 400 mg/dL
• Vitamin D deficiency (\<20ng/ml)
• Male subjects with serum Cr \>1.5 mg/dl or female subjects with Cr \>1.4 mg/dl
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
• Symptomatic kidney stones or gallstones within 6 months prior to baseline (within 30 days of week 52 visit from #09-1 study)
• Acute pancreatitis at the time of baseline (within 30 days of week 52 visit from #09-1 study)
• Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
• Currently taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g. aspirin, ibuprofen, etc.) within 10 days of the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
• Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to the procedure and/or there is a need or expected need to use during the trial 12 months post index procedure
• Currently taking the following medications (at the time of enrollment) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:
• Restricted Medications/Supplements Systemic corticosteroids Drugs known to affect GI motility (e.g. Reglan) Prescription or over-the-counter weight loss medication(s) Medications known to cause significant weight gain (refer to study reference manual (SRM) or weight loss (e.g. chemotherapeutics)
• Currently taking ≥ two of the following medications for type 2 diabetes; MET, SU, DDP-4i and TZD at baseline (within 30 days of week 52 visit from #09-1 study)
• Currently taking medications for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g. GLP1 or insulin) at baseline (within 30 days of week 52 visit from #09-1 study)

Sponsors & Collaborators

• Morphic Medical Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 18, 2014
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2014-11

Data Sharing

• IPD Sharing: Will not share