Obesity, Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.
Detailed description
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality
Interventions
EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.
Sponsors
Morphic Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects Age \> 18 years and ≤65 years - Male or Female * Subjects with Type 2 Diabetes \> 1 and ≤ 10 years in duration * Subjects with an Hb A1c level \> 7.5 and ≤ 10.0 * Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required. * Subjects with a BMI \> 30 and\< 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 contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.
Exclusion criteria
* Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide) * Subjects requiring insulin \>150 units per day • Subjects with probable insulin production failure (fasting C Peptide serum \<1.0 ng/mL) * Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis * Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period * 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 * Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia * Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical study participation * Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant * Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.) * Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder * Subjects with active and uncontrolled gastroesophageal reflux disease (GERD) * Subjects with severe liver or kidney failure (serum creatinine \>180mmol/l) * Subjects with poor dentition who can not adequately chew their food
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (%) Measured at Week 52 | 12 months | — |
| Total Weight Change From Baseline to Week 52 | 12 months | Total weight change at 12 months (kg) compared to baseline |
| Changes in Diabetic Medications at Treatment Completion Compared to Baseline | 12 months | number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion) |
| Change From Baseline in SF 36v2 Quality of Life Assessment | Baseline, 12 months (explant), 6 months post explant (18 months post baseline) | Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoBarrier Gastrointestinal Liner EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | concomitant medication | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | EndoBarrier Gastrointestinal Liner |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 49.9 years STANDARD_DEVIATION 7.97 |
| Baseline glucose | 9.5 mmol/L STANDARD_DEVIATION 2.95 |
| Baseline HbA1c | 8.5 % STANDARD_DEVIATION 0.85 |
| BMI | 40.0 kg/m2 STANDARD_DEVIATION 5.79 |
| Duration of Diabetes | 4.6 years STANDARD_DEVIATION 2.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United Kingdom | 45 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 22 Participants |
| Weight (kg) | 115 kg STANDARD_DEVIATION 21.02 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 45 |
| serious Total, serious adverse events | 13 / 45 |
Outcome results
Primary
Change From Baseline in SF 36v2 Quality of Life Assessment
Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.
Time frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
Population: The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoBarrier Liner Device | Change From Baseline in SF 36v2 Quality of Life Assessment | PCS-Change from Baseline | 1.0 units on a scale | Standard Deviation 9.49 |
| EndoBarrier Liner Device | Change From Baseline in SF 36v2 Quality of Life Assessment | MCS-Change from Baseline | 3.0 units on a scale | Standard Deviation 9.66 |
| Increase in Glucose-Lowering Meds at Week 52 | Change From Baseline in SF 36v2 Quality of Life Assessment | PCS-Change from Baseline | 1.0 units on a scale | Standard Deviation 8.33 |
| Increase in Glucose-Lowering Meds at Week 52 | Change From Baseline in SF 36v2 Quality of Life Assessment | MCS-Change from Baseline | -0.5 units on a scale | Standard Deviation 14.12 |
Primary
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
Time frame: 12 months
Population: Analysis was conducted on subjects with a device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoBarrier Liner Device | Changes in Diabetic Medications at Treatment Completion Compared to Baseline | 23 Participants |
| Increase in Glucose-Lowering Meds at Week 52 | Changes in Diabetic Medications at Treatment Completion Compared to Baseline | 4 Participants |
| No Change in Glucose-Lowering Meds at Week 52 | Changes in Diabetic Medications at Treatment Completion Compared to Baseline | 18 Participants |
Primary
HbA1c (%) Measured at Week 52
Time frame: 12 months
Population: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EndoBarrier Liner Device | HbA1c (%) Measured at Week 52 | 7.3 % glycated hemoglobin |
Primary
Total Weight Change From Baseline to Week 52
Total weight change at 12 months (kg) compared to baseline
Time frame: 12 months
Population: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier Liner Device | Total Weight Change From Baseline to Week 52 | -12.1 kg | Standard Deviation 7 |