Clinical trial NCT06087822: Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
Official title: Randomized, Double-blinded, Placebo-controlled, Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21® in Obese or Overweight Subjects With Elevated Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: Sigrid Therapeutics AB
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, placebo-controlled, multicenter clinical investigation according to Medical Device Regulation article 62
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c level
timeFrame: Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Secondary outcomes:
measure: Body weight
timeFrame: Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Klimed ul. Jana Pawła II 59 lok. 6U,
city: Białystok
country: Poland
facility: RENEW Clinic ul. Gajowa 29,
city: Bychawa
country: Poland
facility: Klimed Bychawa ul. Piłsudskiego 28,
city: Chorzów
country: Poland
facility: Diab Serwis Popenda Spółka Jawna Józefa Ryszki 51,
city: Kraków
country: Poland
facility: Centrum Nowoczesnych Terapii Dobry Lekarz plac Szczepański 3/II,
city: Lublin
country: Poland
facility: Clinical Best Solutions ul. Cicha 4/1,
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II ul. K. Przerwy-Tetmajera 21, 20-362
city: Szczecin
country: Poland
facility: Dom Lekarski Centrum Medyczne Outlet Park ul. Andrzeja Struga 42,
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia ul. Gładka 22,
city: Wrocław
country: Poland
facility: Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu ul.Weigla 5,
city: Łódź
country: Poland
facility: Amicare centrum medyczne Ul. Zgierska 249,
city: Brașov
country: Romania
facility: Neomed Strada Crișului nr. 1,
city: București
country: Romania
facility: Nicodiab Strada Polonă 92, Bl. 17 A+B
city: București
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central 'Dr Carol Davila' Calea Plevnei 134,
city: București
country: Romania
facility: Fundatia Ana Aslan International Strada Vasile Pârvan, nr 12, ap 1, 010216,
city: Cluj-Napoca
country: Romania
facility: RO03 MediPrax Centrum Strada Petru Maior 6-8
city: Muscel
country: Romania
facility: Clubul Sanatatii SRL Strada I. C. Brătianu 54B Cȃmpulung Muscel, Argeş
city: Bratislava, Rača
country: Slovakia
facility: DIABEDA, s.r.o.Zdravotnícke stredisko, Tbiliska 6,
city: Bratislava
country: Slovakia
facility: Metabol KLINIK, s.r.o.Cukrová 3
city: Bratislava
country: Slovakia
facility: Metabolické centrum Dumbierska 32
city: Hlohovec
country: Slovakia
facility: Diversitas s.r.o., SNP 870/10
city: Ilava
country: Slovakia
facility: INTERN, s.r.o. L. Štúra 846/39
city: Levice
country: Slovakia
facility: Všeobecná ambulancia pre dospelých Nábrežná 3043/3
city: Nové mesto nad Váhom
country: Slovakia
facility: SALUBER SK, s.r.o Piešťanská 1166/ 5,
city: Piestany
country: Slovakia
facility: MEDIPA, s.r.o., internist Sládkovicova 2A
city: Pruské
country: Slovakia
facility: Dr. Viliam Cibik, Pruské 293,
city: Trencín
country: Slovakia
facility: MUDr. Dagmar Žáková Súvoz 1
Study officials:
affiliation: Sigrid Therapeutics
name: Maria Klockare
role: STUDY_DIRECTOR
References: