Diabetes Mellitus, Type 2NCT02413567
Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
A study testing DMR Procedure (Fractyl) in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Fractyl Health Inc. at 7 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- What is being tested?
- DMR Procedure (Fractyl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 23 Mar 2015to 18 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 28 -75 years of age
- Diagnosed with Type 2 Diabetes for less than 10 years
- HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
- Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
- On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
- Willing to comply with study requirements and able to understand and comply with informed consent
- Sign an informed consent form
Who cannot join
- Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)
- Current use of Insulin
- Use of Glucagon like peptide (GLP)-1 analogues
- Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
- Known autoimmune disease, as evidenced by a positive anti glutamic acid decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
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- Previous gastrointestinal (GI) surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
- History of chronic or acute pancreatitis
- Known active hepatitis or active liver disease
- Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
- History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- Use of anticoagulation therapy (such as Warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
- Use of P2Y12 inhibitors (clopidrogel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
- Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
- Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
- Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- Persistent Anemia, defined as Hgb < 10 mg/dl
- Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (MDRD) <30 ml/min/1,73m^2
- Active systemic infection
- Active malignancy within the last 5 years
- Not potential candidates for surgery or general anesthesia
- Active illicit substance abuse or alcoholism
- Those who are pregnant, nursing or expect to become pregnant over the course of the study
- Participating in another ongoing clinical trial
- Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
United Kingdom2 sites
University College London Hospitals
London, NW1 2BU
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Italy1 site
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
Rome, Lazio, 00168
About this study
Official title: Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- Being tested
- DMR Procedure (Fractyl)
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMR Procedure (Fractyl)Device
Endoscopic procedure
| Study group | Role | What they receive |
|---|---|---|
| DMR Procedure | Experimental | Subjects receive the endoscopic DMR procedure in this arm Receives: Device: DMR Procedure (Fractyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Measured: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Measured: 24 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start23 Mar 2015
- Primary completion12 Jun 2017
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fractyl Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413567
- Sponsor's protocol ID
- C-20000 A & B
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2015
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Busch CBE, Meiring S, van Baar ACG, Gastaldelli A, DeFronzo R, Mingrone G, Hagen M, White K, Rajagopalan H, Nieuwdorp M, Bergman JJGHM. Insulin sensitivity and beta cell function after duodenal mucosal resurfacing: an open-label, mechanistic, pilot study. Gastrointest Endosc. 2024 Sep;100(3):473-480.e1. doi: 10.1016/j.gie.2024.01.031. Epub 2024 Jan 25.
PubMed 38280531van Baar ACG, Deviere J, Hopkins D, Crenier L, Holleman F, Galvao Neto MP, Becerra P, Vignolo P, Rodriguez Grunert L, Mingrone G, Costamagna G, Nieuwdorp M, Guidone C, Haidry RJ, Hayee B, Magee C, Carlos Lopez-Talavera J, White K, Bhambhani V, Cozzi E, Rajagopalan H, J G H M Bergman J. Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study). Diabetes Res Clin Pract. 2022 Feb;184:109194. doi: 10.1016/j.diabres.2022.109194. Epub 2022 Jan 13.
PubMed 35032562van Baar ACG, Holleman F, Crenier L, Haidry R, Magee C, Hopkins D, Rodriguez Grunert L, Galvao Neto M, Vignolo P, Hayee B, Mertens A, Bisschops R, Tijssen J, Nieuwdorp M, Guidone C, Costamagna G, Deviere J, Bergman JJGHM. Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study. Gut. 2020 Feb;69(2):295-303. doi: 10.1136/gutjnl-2019-318349. Epub 2019 Jul 22.
PubMed 31331994
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 Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02413567
- Acronym / sponsor ID
- C-20000 A & B
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fractyl Health Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
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 evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMR Procedure | Experimental | Device: DMR Procedure (Fractyl)Subjects receive the endoscopic DMR procedure in this arm |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 28 -75 years of age
- Diagnosed with Type 2 Diabetes for less than 10 years
- HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
- Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
- On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
Key exclusion criteria (25 listed)
- Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)
- Current use of Insulin
- Use of Glucagon like peptide (GLP)-1 analogues
- Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
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 |
|---|---|---|
| DMR Procedure (Fractyl)Endoscopic procedure | Device | DMR Procedure |
Primary outcome
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Time frame: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time frame: 24 weeks post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 38280531Busch CBE, Meiring S, van Baar ACG, Gastaldelli A, DeFronzo R, Mingrone G, Hagen M, White K, Rajagopalan H, Nieuwdorp M, Bergman JJGHM. Insulin sensitivity and beta cell function after duodenal mucosal resurfacing: an open-label, mechanistic, pilot study. Gastrointest Endosc. 2024 Sep;100(3):473-480.e1. doi: 10.1016/j.gie.2024.01.031. Epub 2024 Jan 25.
- Derived from this study: PubMed 35032562van Baar ACG, Deviere J, Hopkins D, Crenier L, Holleman F, Galvao Neto MP, Becerra P, Vignolo P, Rodriguez Grunert L, Mingrone G, Costamagna G, Nieuwdorp M, Guidone C, Haidry RJ, Hayee B, Magee C, Carlos Lopez-Talavera J, White K, Bhambhani V, Cozzi E, Rajagopalan H, J G H M Bergman J. Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study). Diabetes Res Clin Pract. 2022 Feb;184:109194. doi: 10.1016/j.diabres.2022.109194. Epub 2022 Jan 13.
- Derived from this study: PubMed 31331994van Baar ACG, Holleman F, Crenier L, Haidry R, Magee C, Hopkins D, Rodriguez Grunert L, Galvao Neto M, Vignolo P, Hayee B, Mertens A, Bisschops R, Tijssen J, Nieuwdorp M, Guidone C, Costamagna G, Deviere J, Bergman JJGHM. Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study. Gut. 2020 Feb;69(2):295-303. doi: 10.1136/gutjnl-2019-318349. Epub 2019 Jul 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DMR Procedure (Fractyl) in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Fractyl Health Inc. at 7 sites in 5 countries.
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 7 sites in Belgium, United Kingdom, Chile, Italy, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure (time frame: 24 weeks post-procedure). The study lists 2 primary outcomes in all. 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 NCT02413567, which also lists 3 linked publications.
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.