Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DMR Procedure (Fractyl)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Sites / Locations
- Hopital Erasme
- UZ Leuven
- Centro Clinico de Obesidad
- Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
- Academic Medical Center
- University College London Hospitals
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DMR Procedure
Arm Description
Subjects receive the endoscopic DMR procedure in this arm
Outcomes
Primary Outcome Measures
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413567
Brief Title
Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
Official Title
Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
September 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fractyl Laboratories, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DMR Procedure
Arm Type
Experimental
Arm Description
Subjects receive the endoscopic DMR procedure in this arm
Intervention Type
Device
Intervention Name(s)
DMR Procedure (Fractyl)
Intervention Description
Endoscopic procedure
Primary Outcome Measure Information:
Title
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
Time Frame
24 weeks post-procedure
Title
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
Time Frame
24 weeks post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
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
Facility Information:
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Centro Clinico de Obesidad
City
Santiago
Country
Chile
Facility Name
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35032562
Citation
van 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.
Results Reference
derived
PubMed Identifier
31331994
Citation
van 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.
Results Reference
derived
Learn more about this trial
Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes
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