Type II Diabetes
Conditions
Brief summary
The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.
Detailed description
The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).
Interventions
DEVICEFractyl Duodenal Remodeling System
Sponsors
Fractyl Health Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants Age \> 28 years and ≤ 75 years 2. Male or Female 3. Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months 4. Participants with an HbA1c \> 7.5 and ≤ 10.0% 5. Participants with a BMI \> 24 and \< 40 6. Participants willing to comply with study requirements and able to understand and comply with informed consent 7. Participants who have signed an informed consent form
Exclusion criteria
1. Participants diagnosed with Type I Diabetes or with a history of ketoacidosis 2. Participants using insulin for more than 12 months 3. Participants with probable insulin production failure (defined as fasting C Peptide serum \<1ng/mL) 4. Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test 5. Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure 6. Participants with iron deficiency anemia - either currently or in their history 7. Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded) 8. Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum, 9. Participants with symptomatic gallstones or kidney stones at the time of screening 10. Participants with a history of pancreatitis 11. Participants with an active systemic infection 12. Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 13. Participants with celiac disease 14. Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled 15. Participants with known active hepatitis or active liver disease 16. Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation 17. Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions 18. Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase 19. Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications 20. Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder 21. Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater 22. Participants with active illicit substance abuse or alcoholism 23. Participants participating in another ongoing investigational clinical trial 24. Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan) 25. Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changed in Mixed Meal Tolerance From Baseline to 3 Months | 3 months | Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months |
Countries
Chile
Participant flow
Pre-assignment details
A screening endoscopy is performed to visually examine the participant's GI tract to ensure they meet the requirements of the exclusion criteria concerning anatomical anomalies that would preclude the ability to complete the treatment. A biopsy is also taken to evaluate the baseline tissue.
Participants by arm
| Arm | Count |
|---|---|
| Duodenal Treatment Fractyl Duodenal Remodeling System | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Duodenal Treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 55 Participants | — |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 8.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Chile | 57 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 36 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 43 / 57 |
| serious Total, serious adverse events | 3 / 57 |
Outcome results
Primary
Changed in Mixed Meal Tolerance From Baseline to 3 Months
Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months
Time frame: 3 months
Population: The 5 subjects who did not receive an ablation were excluded from the efficacy population, yielding 52 subjects in the efficacy population (as-treated population).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodenal Treatment | Changed in Mixed Meal Tolerance From Baseline to 3 Months | FPG with MMTT at 3 months | 145.3 mg/dL | Standard Deviation 53.7 |
| Duodenal Treatment | Changed in Mixed Meal Tolerance From Baseline to 3 Months | FPG with MMTT at Baseline | 180.9 mg/dL | Standard Deviation 53.9 |