Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®

Inclusion Criteria:

1. Male or female 18-70 years old

2. HbA1c level ≥42 to 58 mmol/mol (≥6 to 7.5% - according to Diabetes Control andComplications Trial [DCCT, 1987]) at V1 For Poland only: HbA1c level ≥42 to 53mmol/mol (≥6 to 7% - according to the Official Journal of the Diabetes Poland, 2023Vol. 3 Issue 1) at V1

3. Body mass index (BMI) >25 kg/m2 and 40 kg/m2

4. Regular intake of 3 main meals (self-reported)

5. Readiness and ability to:

6. use the study treatment as recommended and attend all scheduled visits

7. comply with all further study procedures

8. Readiness to maintain the current diet and level of physical activity during thestudy

9. Readiness not to participate in another clinical study during this study

10. Women of childbearing potential: commitment to use medically recognizedcontraception methods during the treatment period

11. Written informed consent by the participant following written and oral informationby the investigator regarding nature, purpose, consequences and possible risks ofthe clinical study

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the IMD or placebo (self-reported)

2. Type 1 diabetes (T1D)/Latent Autoimmune Diabetes in Adult or secondary diabetes (self-reported)

3. Uncontrolled hypertension (regularly >179/109 mmHg [self-reported] and as perinvestigator's judgement based on screening procedures at V1)

4. History (self-reported) of myocardial infarction or stroke 6 months prior to V1

5. Clinically relevant abnormal electrocardiogram (ECG) at V1

6. History (<3 years prior to V1) or presence (self-reported) of:

7. exocrine pancreatic insufficiency, chronic pancreatitis

8. chronic inflammatory bowel disease, celiac disease

9. diverticulosis (usually affecting the large intestine), adhesions, chronicconstipation

10. State after pancreatic head resection with the need for additional intake ofpancreatic enzymes (self-reported)

11. Major surgery of esophagus, stomach, intestine including colon which took place <3years prior to V1, or >3 years prior to V1 in case of related current clinicalsymptoms (self-reported)

12. Clinically significant deviation, based on investigators judgment, in bloodlaboratory values at V1 of blood status (hemoglobin, erythrocytes, platelets,leucocytes, reticulocytes), kidney parameters (creatinine, cystatin C and estimatedglomerular filtration rate), thyroid hormone status: thyroid-stimulating hormone (TSH)

13. Deviation in blood laboratory values at V1 of liver parameters (aspartateaminotransferase [ASAT], alanine transaminase [ALAT], alkaline phosphatase and γ-glutamyl transpeptidase [Gamma-GT]) that is clinically significant based oninvestigators judgment

14. Blood donation/other major blood loss or blood transfusion, that may interfere withthe study as per investigator's judgment, within 56 days prior to V1 and any blooddonation or transfusion during the study

15. Previous or current metformin or other medical anti-diabetic treatment or bloodglucose levels reducing/influencing treatment/supplementation within 30 days priorto V1 and during the study

16. Current treatment/supplementation for weight management (e.g., fat binder/burner,carb blocker, satiety products) or known to influence weight (e.g., systemiccorticosteroids)

17. Medical conditions that require medications taken during meals

18. Extreme diet form (e.g., ketogenic, very low carbohydrate) during the last 3 monthsprior to study

19. Self-reported regular average consumption of >1 L/day total of sugary beverages (e.g., soft drinks, fruit juices, energy drinks) and/or >200 g/day total of foodbased on simple sugar(s) between meals (e.g., commercial candies, dried fruit)

20. Pregnancy, lactation or active planning to achieve pregnancy

21. History of or current abuse of drugs, alcohol or medication

22. Any severe diseases/disorder (e.g., chronic kidney disease, neoplastic disease orpsychiatric disorder) which may interfere with the compliance to the studyprocedures as per investigator's judgement

23. Participation in another study during the last 30 days prior to V1

24. Belonging to a vulnerable population, having any condition or other reason which inthe opinion of the investigator would confound the conduct of the study orinterpretation of the study results

25. Relative of the investigator or an employee at the clinical study site and Sponsor