Type 2 Diabetes
Conditions
Keywords
Diabetes, Weight Loss, GI Dynamics, EndoBarrier
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.
Interventions
DEVICEEndoBarrier Liner
52 week treatment of EnoBarrier Liner
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 55 Years
Healthy volunteers
No
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 * 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 trial participation * Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant * Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period * Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated) * Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications * 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 GERD * Subjects with a known history of substance abuse * Subjects participating in another ongoing investigational clinical trial * Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Glycemic Control (HbA1c) Over Time | Baseline to 12 Months with device implanted | HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12 |
| Change in Anti-diabetes Medications | 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
| Measure | Time frame |
|---|---|
| Total Weight Change (kg) at Week 52 Compared to Baseline Weight | Baseline to 52 weeks |
Other
| Measure | Time frame |
|---|---|
| Fasting Plasma Glucose Over Time for All Subjects | Baseline to 12 months post Device Explant |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoBarrier Liner Device EndoBarrier Liner: 52 week treatment of EndoBarrier Liner | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | device migration | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Unsuccessful implant procedure | 3 |
Baseline characteristics
| Characteristic | EndoBarrier Liner Device |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 6.69 |
| Gender Female | 7 Participants |
| Gender Male | 13 Participants |
| Region of Enrollment Brazil | 20 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Assessment of Glycemic Control (HbA1c) Over Time
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Time frame: Baseline to 12 Months with device implanted
Population: 20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EndoBarrier Liner Device at Baseline | Assessment of Glycemic Control (HbA1c) Over Time | 8.7 HbA1c % |
| EndoBarrier Liner Device at 3 Months | Assessment of Glycemic Control (HbA1c) Over Time | 6.7 HbA1c % |
| EndoBarrier Liner Device % at 6 Months | Assessment of Glycemic Control (HbA1c) Over Time | 6.9 HbA1c % |
| EndoBarrier Liner Device % at 9 Months | Assessment of Glycemic Control (HbA1c) Over Time | 6.9 HbA1c % |
| EndoBarrier Liner Device % at 52 Weeks | Assessment of Glycemic Control (HbA1c) Over Time | 6.8 HbA1c % |
Primary
Change in Anti-diabetes Medications
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.
Time frame: Baseline to 52 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoBarrier Liner Device at Baseline | Change in Anti-diabetes Medications | 9 Participants |
| EndoBarrier Liner Device at 3 Months | Change in Anti-diabetes Medications | 0 Participants |
| EndoBarrier Liner Device % at 6 Months | Change in Anti-diabetes Medications | 7 Participants |
Secondary
Total Weight Change (kg) at Week 52 Compared to Baseline Weight
Time frame: Baseline to 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoBarrier Liner Device at Baseline | Total Weight Change (kg) at Week 52 Compared to Baseline Weight | -6.3 kg | Standard Deviation 4.05 |
Other Pre-specified
Fasting Plasma Glucose Over Time for All Subjects
Time frame: Baseline to 12 months post Device Explant
Population: Subjects with a Successful Device Implant Procedure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | Baseline | 10.9 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | Month 3 | 7.3 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | Month 6 | 7.5 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | Month 9 | 7.6 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | Month 12 | 7.6 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | 3 Months Post-Explant | 7.4 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | 6 Months Post-Explant | 8.3 mmol/L |
| EndoBarrier Liner Device at Baseline | Fasting Plasma Glucose Over Time for All Subjects | 12 Months Post-Explant | 8.9 mmol/L |