Type II DiabetesNCT01927562

Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

A study testing Fractyl Duodenal Remodeling System in people with Type II Diabetes, run by Fractyl Health Inc. at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 28 to 75 years
Conditions the study is for: Type II Diabetes
What is being tested?: Fractyl Duodenal Remodeling System
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteChile
Study dates: 13 Jul 2013to 16 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 28 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants Age > 28 years and ≤ 75 years
Male or Female
Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
Participants with an HbA1c > 7.5 and ≤ 10.0%
Participants with a BMI > 24 and < 40
Participants willing to comply with study requirements and able to understand and comply with informed consent
Participants who have signed an informed consent form

Who cannot join

Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
Participants using insulin for more than 12 months
Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
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
Participants with iron deficiency anemia - either currently or in their history

Show all 25Show fewer

Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
Participants with symptomatic gallstones or kidney stones at the time of screening
Participants with a history of pancreatitis
Participants with an active systemic infection
Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
Participants with celiac disease
Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
Participants with known active hepatitis or active liver disease
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
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
Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
Participants with active illicit substance abuse or alcoholism
Participants participating in another ongoing investigational clinical trial
Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia

Trial locations and contacts

1 site in 1 country.

Chile1 site

INDISA
Santiago

Other trials in Chile

About this study

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

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.

Read the 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).

Conditions: Type II Diabetes
Being tested: Fractyl Duodenal Remodeling System
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fractyl Duodenal Remodeling SystemDevice

Study groups in NCT01927562
Study group	Role	What they receive
Duodenal Treatment	Experimental	The Duodenal Remodeling procedure utilizes both a trans-oral over the wire and endoscopic approach to minimally invasively ablating and remodeling the duodenum. Receives: Device: Fractyl Duodenal Remodeling System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201316 Mar 2018

First posted22 Aug 2013 (estimated)
Study start13 Jul 2013
Primary completion7 Apr 2017
Study completion16 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type II DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01927562
Sponsor's protocol ID: C-10000
Status last verified: Feb 2024
First submitted: 20 Aug 2013
Last updated: 14 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rajagopalan H, Cherrington AD, Thompson CC, Kaplan LM, Rubino F, Mingrone G, Becerra P, Rodriguez P, Vignolo P, Caplan J, Rodriguez L, Galvao Neto MP. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Diabetes Care. 2016 Dec;39(12):2254-2261. doi: 10.2337/dc16-0383. Epub 2016 Aug 12.
PubMed 27519448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type II Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes
ClinicalTrials.gov ID: NCT01927562
Acronym / sponsor ID: C-10000
Conditions: Type II Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Fractyl Health Inc.Industry (pharma, biotech, devices)
Study start: 13 Jul 2013 (actual)
Primary completion: 7 Apr 2017 (actual)
Study completion: 16 Mar 2018 (actual)
First posted: 22 Aug 2013 (estimated)
Results: Posted 24 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Duodenal Treatment	Experimental	Device: Fractyl Duodenal Remodeling SystemThe Duodenal Remodeling procedure utilizes both a trans-oral over the wire and endoscopic approach to minimally invasively ablating and remodeling the duodenum.

Who may qualify

Ages: 28 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participants Age > 28 years and ≤ 75 years
Male or Female
Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
Participants with an HbA1c > 7.5 and ≤ 10.0%
Participants with a BMI > 24 and < 40

Key exclusion criteria (25 listed)

Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
Participants using insulin for more than 12 months
Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fractyl Duodenal Remodeling System	Device	Duodenal Treatment

Primary outcome

Changed in Mixed Meal Tolerance From Baseline to 3 Months
Time frame: 3 months
Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duodenal Treatment	57	19

Primary outcome: Changed in Mixed Meal Tolerance From Baseline to 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: mg/dL

Measure	Duodenal Treatment n = 52
FPG with MMTT at 3 months	145.3 (53.7)
FPG with MMTT at Baseline	180.9 (53.9)

Population analysed: 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).

Adverse events

Time frame: Adverse events were collected for each participant from the time of informed consent through end of study (up to 36 months after study procedure).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duodenal Treatment	3 of 57 (5.3%)	43 of 57 (75.4%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27519448Rajagopalan H, Cherrington AD, Thompson CC, Kaplan LM, Rubino F, Mingrone G, Becerra P, Rodriguez P, Vignolo P, Caplan J, Rodriguez L, Galvao Neto MP. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Diabetes Care. 2016 Dec;39(12):2254-2261. doi: 10.2337/dc16-0383. Epub 2016 Aug 12.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leonard R Gomez, MD principal investigator

Centro Clinico De La Obesidad

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fractyl Duodenal Remodeling System in people with Type II Diabetes, run by Fractyl Health Inc. at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changed in Mixed Meal Tolerance From Baseline to 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01927562, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.