Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Nobix System: Type of Device: Implant
Frequency: Once
Route of Insertion: Endoscopically from mouth
Study Duration: 40 Weeks
Control Intervention1: NA: NA
Sponsors
Allevetix Medical Ltd
CBCC Global Research LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients 2. Patient is at least 18 years old 3. Anticipated life expectancy of at least 1 year from enrolment 4. Patient providing written Informed Consent prior to any study related procedures 5. Patient is willing to comply with the Clinical Investigational Plan (CIP) requirements including return to the study center for all required clinical evaluations 6. Patients with baseline BMI of greater than equal to 30 kg per m2 and less than equal to 45 kg per m2 7. Type II Diabetes mellitus with HbA1c greater than equal to 7 in the 6 months before enrolment 8. Sexually active women, unless surgically sterile or post-menopausal, must use one of the following methods to avoid pregnancy during the study: 1. Abstinence from penile/vaginal intercourse during the study; 2. Double barrier contraceptive methods one of which must be a condom
Exclusion criteria
Exclusion criteria: 1. Use of weight loss medications, or appetite suppressants during one month prior to enrollment. 2. Use of non-steroidal anti-inflammatory drugs, corticosteroids, and drugs known to affect gastrointestinal motility during 3 months prior to enrollment. 3. Patients who have taken Antiplatelet medications, Coumadin or Direct Oral Anti-coagulants 10 days prior to the device placement. 4. Recent Pancreatitis in the last 1 month, any history of coronary artery disease, Chronic Obstructive Pulmonary Disease (COPD), biliary disease (gallstone, choledocholithiasis), severe coagulopathy. 5. History of congenital or acquired gastrointestinal tract disorders, including gastrointestinal bleeding conditions 6. Patients having anemia/ iron deficiency 7. Patients with known peptic ulcer, gastritis, duodenitis, esophagitis, varices 8. History or symptoms of scleroderma 9. Previous surgery in the gastrointestinal tract that could affect the ability to place the study device 10. Current active infection (excluding H. pylori infection for which antibiotic treatment is initiated10 days before device implantation) 11. Any malignancy 12. HIV, HCV, HBV positive 13. Alcohol abuse 14. Pregnant female or intention to become pregnant during the study period 15. Patients with confirmed novel coronavirus infection (COVID-19) 16. Any other medical condition or serious intercurrent illness that, in the opinion of the Principal Investigator, may make it undesirable for the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: Incidence and severity of device and procedure-related adverse events. Efficacy Endpoints: 1. Change in HbA1c compared to baseline up to 12 weeks post device removal 2. Percentage of weight loss compared to baseline up to 12 weeks post device removal Study Duration: 40 Weeks Timepoint: Primary endpoint will be assessed at baseline visit and day 36nweek visit, These two visits are considered as time points at which change in body weight and change HbA1C will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed