Type 2 DiabetesNCT03130244
Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
A study testing Magnet Anastomosis System and Best Medical Management in people with Type 2 Diabetes and Obesity, run by GI Windows, Inc. at 1 site in Argentina.
Trial summary
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Magnet Anastomosis System and Best Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteArgentina
- Study dates
- 23 Sep 2019to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) 30 to 50.
- Subject Type 2 Diabetes Criteria:
- T2DM diagnosis ≥6 months but < 10 years
- On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
- Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., <0.3% reduction)
- Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
Show all 9Show fewer
- If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
- Able to understand and sign informed consent document
- Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions
Who cannot join
- Known or suspected allergy to nickel or titanium or Nitinol
- Type 1 Diabetes
- Use of injectable insulin
- Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
- Probable insulin production failure, defined as fasting serum C Peptide <1 ng/mL (0.3 nmol/l)
- Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
Show all 16Show fewer
- Contraindication to general anesthesia
- Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
- Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
- Previous technically difficult or failed colonoscopy or endoscopy
- If on metformin, history of polycystic ovarian syndrome (PCOS)
- Unable or unwilling to perform home blood glucose monitoring
- History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
- Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
- Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
- Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
Read the detailed description
Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Magnet Anastomosis System, Best Medical Management
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet Anastomosis SystemDevice
Also called MAS
The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes.
Best Medical ManagementDrug
Also called No other intervention
The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.
| Study group | Role | What they receive |
|---|---|---|
| Device Placement | Active comparator | The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created. Receives: Device: Magnet Anastomosis System; Drug: Best Medical Management |
| Control | No intervention | The patients in this arm will receive the best medical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HbA1c
The primary effectiveness endpoint is Mean change in HbA1c from baseline
Measured: 12 months
Secondary outcomes (3)
Mean change in Weight
12 month weight loss measured as a percent of total body weight loss and excess weight loss (using the BMI method) as well as weight/BMI change from baseline
Measured: 12 months
Proportion of subjects achieving remission
Proportion of subjects experiencing diabetes remission and/or partial remission at 12 months (as defined by the American Diabetes Association)
Measured: 12 months
Mean change in diabetes medication
Change in diabetes medication requirements from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start23 Sep 2019
- Primary completion15 Jan 2026
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rudolf H Buxhoeveden, Principal investigator, Bariatric Surgeon at Hospital Aleman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130244
- Sponsor's protocol ID
- GIW 16-001
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2017
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03130244
- Acronym / sponsor ID
- GIW 16-001
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 26 Apr 2017 (actual)
- 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.
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
Detailed description
Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Placement | Active comparator | Device: Magnet Anastomosis System, Drug: Best Medical ManagementThe patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created. |
| Control | No intervention | –The patients in this arm will receive the best medical management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body mass index (BMI) 30 to 50.
- Subject Type 2 Diabetes Criteria:
- If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
- Able to understand and sign informed consent document
- Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions
Key exclusion criteria (16 listed)
- Known or suspected allergy to nickel or titanium or Nitinol
- Type 1 Diabetes
- Use of injectable insulin
- Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
- Probable insulin production failure, defined as fasting serum C Peptide <1 ng/mL (0.3 nmol/l)
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 |
|---|---|---|
| Magnet Anastomosis SystemAlso: MASThe MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes. | Device | Device Placement |
| Best Medical ManagementAlso: No other interventionThe best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters. | Drug | Device Placement |
Primary outcome
Mean change in HbA1c
Time frame: 12 months
The primary effectiveness endpoint is Mean change in HbA1c from baseline
3 secondary outcomes
Mean change in Weight
Time frame: 12 months
Proportion of subjects achieving remission
Time frame: 12 months
Mean change in diabetes medication
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Rudolf H Buxhoeveden principal investigator
Bariatric Surgeon at Hospital Aleman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet Anastomosis System and Best Medical Management in people with Type 2 Diabetes and Obesity, run by GI Windows, Inc. at 1 site in Argentina.
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 9 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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 Argentina. 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?
This study is still under way. Results are not available in the source record yet.
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 change in HbA1c (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.