Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Type II Diabetes Clinical Trial

Official title:

Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927562
• Other study ID #: C-10000
• Status: Completed
• Phase: N/A
• Start date: July 13, 2013
• Est. completion date: March 16, 2018

Study information

• Verified date: February 2024
• Source: Fractyl Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 16, 2018
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Device:
• Fractyl Duodenal Remodeling System

Locations

Country	Name	City	State
Chile	INDISA	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Fractyl Health Inc.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3 months