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

NCT06087822 | Completed

• 1 other identifier: SITH/001921
• Study Type: interventional
• Target: 318
• Locations: 3 countries
• Sites: 27

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Body weight

  Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.

Study Arms (2)

IMD SiPore21®

EXPERIMENTAL

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

Device: IMD SiPore21®

Placebo Comparator

PLACEBO COMPARATOR

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

Device: IMD SiPore21®

Interventions

IMD SiPore21® DEVICE

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

IMD SiPore21®; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male or female 18-70 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-70 years old
• 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
• Body mass index (BMI) \>25 kg/m2 and 40 kg/m2
• Regular intake of 3 main meals (self-reported)
• Readiness and ability to:
• use the study treatment as recommended and attend all scheduled visits
• comply with all further study procedures
• Readiness to maintain the current diet and level of physical activity during the study
• Readiness not to participate in another clinical study during this study
• Women of childbearing potential: commitment to use medically recognized contraception methods during the treatment period
• 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

You may not qualify if:

• Known allergy or hypersensitivity to the components of the IMD or placebo (self-reported)
• Type 1 diabetes (T1D)/Latent Autoimmune Diabetes in Adult or secondary diabetes (self-reported)
• Uncontrolled hypertension (regularly \>179/109 mmHg \[self-reported\] and as per investigator's judgement based on screening procedures at V1)
• History (self-reported) of myocardial infarction or stroke 6 months prior to V1
• Clinically relevant abnormal electrocardiogram (ECG) at V1
• History (\<3 years prior to V1) or presence (self-reported) of:
• exocrine pancreatic insufficiency, chronic pancreatitis
• chronic inflammatory bowel disease, celiac disease
• diverticulosis (usually affecting the large intestine), adhesions, chronic constipation
• State after pancreatic head resection with the need for additional intake of pancreatic enzymes (self-reported)
• 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)
• 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)
• 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
• 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
• 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

Sponsors & Collaborators

• Sigrid Therapeutics AB: lead

Study Sites (27)

Klimed ul. Jana Pawła II 59 lok. 6U,

Bialystok, 15-704, Poland

Location

RENEW Clinic ul. Gajowa 29,

Bialystok, 15-794, Poland

Location

Klimed Bychawa ul. Piłsudskiego 28,

Bychawa, 23-100, Poland

Location

Diab Serwis Popenda Spółka Jawna Józefa Ryszki 51,

Chorzów, 41-500, Poland

Location

Centrum Nowoczesnych Terapii Dobry Lekarz plac Szczepański 3/II,

Krakow, 31-011, Poland

Location

Amicare centrum medyczne Ul. Zgierska 249,

Lodz, 91-495, Poland

Location

Clinical Best Solutions ul. Cicha 4/1,

Lublin, 20-078, Poland

Location

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

Lublin, 20-362, Poland

Location

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

Szczecin, 70-784, Poland

Location

MTZ Clinical Research Powered by Pratia ul. Gładka 22,

Warsaw, 02-172, Poland

Location

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

Wroclaw, 50-981, Poland

Location

Neomed Strada Crișului nr. 1,

Brasov, 500283, Romania

Location

Nicodiab Strada Polonă 92, Bl. 17 A+B

Bucharest, 010507, Romania

Location

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

Bucharest, 010825, Romania

Location

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

Bucharest, Romania

Location

RO03 MediPrax Centrum Strada Petru Maior 6-8

Cluj-Napoca, 400002, Romania

Location

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

Mușcel, 115100, Romania

Location

Metabol KLINIK, s.r.o.Cukrová 3

Bratislava, 811 08, Slovakia

Location

Metabolické centrum Dumbierska 32

Bratislava, 831 01, Slovakia

Location

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

Bratislava - Rača, 831 06, Slovakia

Location

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

Hlohovec, 920 01, Slovakia

Location

INTERN, s.r.o. L. Štúra 846/39

Ilava, 01901, Slovakia

Location

Všeobecná ambulancia pre dospelých Nábrežná 3043/3

Levice, 934 05, Slovakia

Location

SALUBER SK, s.r.o Piešťanská 1166/ 5,

Nové Mesto nad Váhom, 915 01, Slovakia

Location

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

Piešťany, 921 01, Slovakia

Location

Dr. Viliam Cibik, Pruské 293,

Pruské, 018 52, Slovakia

Location

MUDr. Dagmar Žáková Súvoz 1

Trencín, 911 01, Slovakia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Klockare

  Sigrid Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The IMD and placebo are comparable in appearance, texture, taste, and smell, and indistinguishable in packaging and labelling, so that study participants, CRO and investigators are blinded to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blinded, placebo-controlled, multicenter clinical investigation according to Medical Device Regulation article 62

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 18, 2023
• Study Start: October 5, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (10); PL (11); RO (6)