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

Overweight or Obesity Clinical Trial

— SHINE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087822
• Other study ID #: SITH/001921
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Sigrid Therapeutics AB
• Contact: Maria Klockare
• Phone: +46706232505
• Email: maria[@]sigridthx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ?-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

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Device:
• IMD SiPore21®
The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c

Locations

Country	Name	City	State
Poland	Klimed ul. Jana Pawla II 59 lok. 6U,	Bialystok
Poland	RENEW Clinic ul. Gajowa 29,	Bialystok
Poland	Klimed Bychawa ul. Pilsudskiego 28,	Bychawa
Poland	Diab Serwis Popenda Spólka Jawna Józefa Ryszki 51,	Chorzów
Poland	Centrum Nowoczesnych Terapii Dobry Lekarz plac Szczepanski 3/II,	Kraków
Poland	Amicare centrum medyczne Ul. Zgierska 249,	Lódz
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. Gladka 22,	Warszawa
Poland	Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ we Wroclawiu ul.Weigla 5,	Wroclaw
Romania	Neomed Strada Cri?ului nr. 1,	Bra?ov
Romania	Fundatia Ana Aslan International Strada Vasile Pârvan, nr 12, ap 1, 010216,	Bucure?ti
Romania	Nicodiab Strada Polona 92, Bl. 17 A+B	Bucure?ti
Romania	Spitalul Universitar de Urgenta Militar Central 'Dr Carol Davila' Calea Plevnei 134,	Bucure?ti
Romania	RO03 MediPrax Centrum Strada Petru Maior 6-8	Cluj-Napoca
Romania	Clubul Sanatatii SRL Strada I. C. Bratianu 54B C?mpulung Muscel, Arges	Muscel
Slovakia	Metabol KLINIK, s.r.o.Cukrová 3	Bratislava
Slovakia	Metabolické centrum Dumbierska 32	Bratislava
Slovakia	DIABEDA, s.r.o.Zdravotnícke stredisko, Tbiliska 6,	Bratislava, Raca
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 Pieštanská 1166/ 5,	Nové mesto nad Váhom
Slovakia	MEDIPA, s.r.o., internist Sládkovicova 2A	Piestany
Slovakia	Dr. Viliam Cibik, Pruské 293,	Pruské
Slovakia	MUDr. Dagmar Žáková Súvoz 1	Trencín

Sponsors (1)

Lead Sponsor	Collaborator
Sigrid Therapeutics AB

Countries where clinical trial is conducted

Poland,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c level	To evaluate if the IMD treatment leads to a greater reduction in HbA1c level (relative to baseline) in comparison to placebo, in obese or overweight subjects with elevated blood glucose levels.	Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Secondary	Body weight	To evaluate if the IMD treatment leads to a greater reduction in body weight (relative to baseline) in comparison to placebo.	Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.