STAR Study Investigating Performance and Safety of the Medical Device SiPore15™

Open-label, Single-arm, Multicenter Study Investigating Performance and Safety of SiPore15™ in Obese and Overweight Subjects With Prediabetes or Newly Diagnosed Type 2 Diabetes

The primary objective of STAR01 is to evaluate the performance and safety of the medical device (class IIb) SiPore15™ after a 12-week long treatment in the target population of obese and overweight subjects with prediabetes or newly diagnosed type 2 diabetes. The expected performance and safety of the device is based on the safety and efficacy results seen in an earlier First-in-Man (FIM) study. The safety and tolerability of SiPore15™ is based on the well-established and extensive use of food grade silicon dioxide and favorable data from the FIM study. Data on side-effects will be collected for verification of device safety. The study duration is 24 weeks in total, 12 weeks from baseline on investigational medicinal device (IMD) treatment, with additional 12 weeks off treatment. The study population is planned for forty (40) subjects to be enrolled, male and females, age >18 years and fulfilling all inclusion criteria but none of the exclusion criteria.

Study Overview

• Status: Completed
• Conditions: Overweight; PreDiabetes; Prediabetic State; Type2 Diabetes; Obese; Type2 Diabetes Mellitus; Pre Diabetes
• Intervention / Treatment: Device: SiPore15™

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70100
    • Pihlajalinna Ite, Satucon OY
• Sweden
  • Uppland
    • Uppsala, Uppland, Sweden, 752 37
      • Clinical Trial Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent form.
2. Male or female aged ≥18 years on the day of screening.
3. Female subjects of childbearing potential must be on non-oral contraceptives, postmenopausal or sterile.
4. Prediabetes or newly diagnosed T2D (not on blood sugar lowering drugs) defined as HbA1c levels: ≥42 to ≤57 mmol/mol (≥6.0 to ≤7.5%-according to DCCT).
5. Body mass index (BMI) >25 kg/m2 and > or = 40 kg/m2.
6. Stable weight for 3 months (+/-5 kg).
7. No extreme changes in diet for the last 6 months such as anorexia, bulimia, etc.
8. Subject must be able and willing to attend all scheduled visits and comply with all study procedures with no planned holiday longer than 2 weeks during the 12 weeks of treatment.

Exclusion Criteria:

1. Diagnosed with type1 diabetes/Latent Autoimmune Diabetes in Adult (LADA) or secondary diabetes, as part of medical history or confirmed by laboratory test.
2. Previous or current Metformin treatment or other glucose reducing drug therapy within 3 months before screening visit.
3. Previous or current statin treatment or other blood lipid (LDL) reducing drug therapy, within 12 months before screening visit.
4. Previous or current medication known to cause weight loss or weight gain, such as systemic corticosteroids, thyroid hormones or Estrogen, within 1 month before screening visit.
5. Subjects who stopped smoking within 6 months before screening visit.
6. Diagnosed with chronic somatic diseases, except for obesity and treatment naive T2D, that in the opinion of the investigator may therefore affect metabolic and /or intestinal function (e.g. inflammatory bowel disease, intestinal dysfunction, pancreatic dysfunction, other causes of malabsorption, recent (past 6 months) neoplastic disease.
7. Any history of myocardial infarction or stroke within the 6 months before screening visit.
8. Anemia, donated blood or other major blood loss within 3 months from screening visit that in the opinion of the clinician may interfere with the study.
9. Pregnancy or breast feeding.
10. Allergies to silicon dioxide.
11. A diagnosed state that requires use of vitamin and/or mineral supplements during the study.
12. Previous major gastric surgery that may affect the study outcome, such as bariatric surgery.
13. Ongoing or unstable kidney condition with moderate to great reduction in glomerular filtration rate < 90 ml/min (GFR) that may affect metabolic parameters during the trial.
14. Ongoing or unstable liver condition that may cause changes in liver enzymes exceeding 2x upper normal levels.
15. Psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
16. History of or ongoing alcohol or drug addiction.
17. Participation in any study involving an investigational drug or medical device within the past 30 days before the screening visit.
18. Belongs to a vulnerable population or has any condition such that his/her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner).
19. Is a relative of the Investigator or an employee at the clinical study site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm; The device will be taken before three daily main meals togteher with water. The dose will be escalated from 1g per main meal to the full dose of 3g per main meal. The device is provided in foil stick-packs packed in boxes with weekly supply. The treatment is for 12 weeks.	Device: SiPore15™; SiPore15™ is a taste- and odourless white powder, consisting of precisely engineered micrometre sized synthetic amorphous silicon dioxide. The device is made of pure silicon dioxide, SiO2, which has the CAS Number: 112926-00-8 and EC List number: 601-214-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance measured as changes in HbA1c	To measure change in long-term blood glucose levels, HbA1c, from baseline (week 1) to end- -of-treatment (week 12).	From week 1 to week 12
Tolerability measured as evaluation of Adverse Events	To assess safety and tolerability by evaluating the frequency and incidence of both adverse events (AEs) and device related adverse events (ADEs) during the study treatment and follow-up, from baseline (week 1) until week 14.	From week 1 to week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance measured as changes in LDL-C	To measure change in LDL-C blood levels from baseline (week 1) to week 6 and end-of- treatment (week 12).	From week 1 to week 12
Performance measured as changes in body fat %	To measure change in body fat levels (bio electric impedance, BIA) from baseline (week 1) to week 6 and end-of-treatment (week 12).	From week 1 to week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint on Medical Device Usability	To assess Medical Device Usability by collecting data: a. Collect information on Ease of use (Easy, neither/nor, difficult) at visit week 2, 6 and end-of -treatment.	From week 1 to week 12
Explorative Endpoint on changes in Cholesterol	To measure change in total Cholesterol levels from baseline to week 6 and end-of-treatment.	From week 1 to week 12
Explorative Endpoint on changes in microbiome diversity (species not defined)	To explore changes in microbiome by feces sampling for research at baseline and at week 24.	From week 1 to week 24

Collaborators and Investigators

• Sponsor: Sigrid Therapeutics AB
• Investigators: Study Chair: Kirsi Pietiläinen, Prof., Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki

Publications and helpful links

General Publications

• Baek J, Robert-Nicoud G, Herrera Hidalgo C, Borg ML, Iqbal MN, Berlin R, Lindgren M, Waara E, Uddén A, Pietiläinen K, Bengtsson T. Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics. Nanomedicine (Lond). 2022 Jan;17(1):9-22. doi: 10.2217/nnm-2021-0235. Epub 2021 Dec 2.

Helpful Links

• Information about the site and study in Kuopio, Finland
• Information about the site and study in Uppsala, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): October 2, 2019
• Study Completion (Actual): October 2, 2019

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Prediabetes; Medical Device; Type2 Diabetes; Silica; Metabolic risk factors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: STAR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No