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

NCT ID: NCT06087822

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2024-07-30

Brief Summary

The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.

Detailed Description

The proposed investigation is set out to be a randomized, double blind, placebo-controlled, multicenter study according to MDR Article 62 to investigate performance and safety of the medical device SiPore21® in subjects with obesity or overweight and elevated blood glucose levels.

The aim of this clinical investigation is to evaluate the clinical performance of the IMD for blood glucose control and its clinical safety. The endpoints selected to evaluate the effects of the IMD are based on the state-of-the-art assessments of blood glucose control (ADA, 2022).

The main hypothesis is that treatment with SiPore21® for 12 weeks will reduce the HbA1c in obese or overweight subjects with elevated blood glucose levels. It is further hypothesized that treatment with SiPore21® for 12 weeks will result in a reduction in body weight and influence metabolic control parameters and lipid levels.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IMD SiPore21®

IMD Class IIb Total daily dose: 3 stick packs (1 x 3 main meals) uration 12 weeks

Group Type: EXPERIMENTAL

IMD SiPore21®

Intervention Type: DEVICE

The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Placebo Comparator

Placebo Total daily dose: 3 stick packs (1 x 3 main meals) duration 12 weeks

Group Type: PLACEBO_COMPARATOR

IMD SiPore21®

Intervention Type: DEVICE

The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Interventions

IMD SiPore21®

The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Intervention Type: DEVICE

Eligibility Criteria

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 and Complications Trial [DCCT, 1987]) at V1 For Poland only: HbA1c level ≥42 to 53 mmol/mol (≥6 to 7% - according to the Official Journal of the Diabetes Poland, 2023 Vol. 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:

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

2. comply with all further study procedures

6. Readiness to maintain the current diet and level of physical activity during the study

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

8. Women of childbearing potential: commitment to use medically recognized contraception methods during the treatment period

9. Written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the 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 per investigator'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:

1. exocrine pancreatic insufficiency, chronic pancreatitis

2. chronic inflammatory bowel disease, celiac disease

3. diverticulosis (usually affecting the large intestine), adhesions, chronic constipation

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

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

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

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

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

12. Previous or current metformin or other medical anti-diabetic treatment or blood glucose levels reducing/influencing treatment/supplementation within 30 days prior to V1 and during the study

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

14. Medical conditions that require medications taken during meals

15. Extreme diet form (e.g., ketogenic, very low carbohydrate) during the last 3 months prior to study

16. 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 food based on simple sugar(s) between meals (e.g., commercial candies, dried fruit)

17. Pregnancy, lactation or active planning to achieve pregnancy

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

19. Any severe diseases/disorder (e.g., chronic kidney disease, neoplastic disease or psychiatric disorder) which may interfere with the compliance to the study procedures as per investigator's judgement

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

21. Belonging to a vulnerable population, having any condition or other reason which in the opinion of the investigator would confound the conduct of the study or interpretation of the study results

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sigrid Therapeutics AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Klockare

Role: STUDY_DIRECTOR

Sigrid Therapeutics

Locations

Klimed ul. Jana Pawła II 59 lok. 6U,

Bialystok, , Poland

RENEW Clinic ul. Gajowa 29,

Bialystok, , Poland

Klimed Bychawa ul. Piłsudskiego 28,

Bychawa, , Poland

Diab Serwis Popenda Spółka Jawna Józefa Ryszki 51,

Chorzów, , Poland

Centrum Nowoczesnych Terapii Dobry Lekarz plac Szczepański 3/II,

Krakow, , Poland

Amicare centrum medyczne Ul. Zgierska 249,

Lodz, , Poland

Clinical Best Solutions ul. Cicha 4/1,

Lublin, , Poland

KO-MED Centra Kliniczne Lublin II ul. K. Przerwy-Tetmajera 21, 20-362

Lublin, , Poland

Dom Lekarski Centrum Medyczne Outlet Park ul. Andrzeja Struga 42,

Szczecin, , Poland

MTZ Clinical Research Powered by Pratia ul. Gładka 22,

Warsaw, , Poland

Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu ul.Weigla 5,

Wroclaw, , Poland

Neomed Strada Crișului nr. 1,

Brasov, , Romania

Nicodiab Strada Polonă 92, Bl. 17 A+B

Bucharest, , Romania

Spitalul Universitar de Urgenta Militar Central 'Dr Carol Davila' Calea Plevnei 134,

Bucharest, , Romania

Fundatia Ana Aslan International Strada Vasile Pârvan, nr 12, ap 1, 010216,

Bucharest, , Romania

RO03 MediPrax Centrum Strada Petru Maior 6-8

Cluj-Napoca, , Romania

Clubul Sanatatii SRL Strada I. C. Brătianu 54B Cȃmpulung Muscel, Argeş

Mușcel, , Romania

Metabol KLINIK, s.r.o.Cukrová 3

Bratislava, , Slovakia

Metabolické centrum Dumbierska 32

Bratislava, , Slovakia

DIABEDA, s.r.o.Zdravotnícke stredisko, Tbiliska 6,

Bratislava - Rača, , Slovakia

Diversitas s.r.o., SNP 870/10

Hlohovec, , Slovakia

INTERN, s.r.o. L. Štúra 846/39

Ilava, , Slovakia

Všeobecná ambulancia pre dospelých Nábrežná 3043/3

Levice, , Slovakia

SALUBER SK, s.r.o Piešťanská 1166/ 5,

Nové Mesto nad Váhom, , Slovakia

MEDIPA, s.r.o., internist Sládkovicova 2A

Piešťany, , Slovakia

Dr. Viliam Cibik, Pruské 293,

Pruské, , Slovakia

MUDr. Dagmar Žáková Súvoz 1

Trencín, , Slovakia

Countries

Poland; Romania; Slovakia

Other Identifiers

SITH/001921

Identifier Type: -

Identifier Source: org_study_id