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

• ClinicalTrials.gov Identifier: NCT03823027
• Recruitment Status: Completed
• First Posted: January 30, 2019
• Last Update Posted: November 5, 2019
• Sponsor: Sigrid Therapeutics AB
• Information provided by (Responsible Party): Sigrid Therapeutics AB

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
PreDiabetes; Pre Diabetes; Prediabetic State; Type2 Diabetes; Type2 Diabetes Mellitus; Overweight; Obese	Device: SiPore15™	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The single-arm study is designed to collect data on changes over time, i.e. comparing the pre-treatment/baseline value with the value achieved after full treatment (12 weeks). Thus, each individual act as his/her own control. The study design has been discussed with notified bodies, and deemed appropriate as there is no state-of-the-art pharmacotherapy for treatment of prediabetes to compare with.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: January 28, 2019
• Actual Primary Completion Date: October 2, 2019
• Actual Study Completion Date: October 2, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Performance measured as changes in HbA1c [ Time Frame: From week 1 to week 12 ]
   To measure change in long-term blood glucose levels, HbA1c, from baseline (week 1) to end- -of-treatment (week 12).
2. Tolerability measured as evaluation of Adverse Events [ Time Frame: From week 1 to week 14 ]
   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.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Exploratory Endpoint on Medical Device Usability [ Time Frame: From week 1 to week 12 ]

   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.

2. Explorative Endpoint on changes in Cholesterol [ Time Frame: From week 1 to week 12 ]
   To measure change in total Cholesterol levels from baseline to week 6 and end-of-treatment.
3. Explorative Endpoint on changes in microbiome diversity (species not defined) [ Time Frame: From week 1 to week 24 ]
   To explore changes in microbiome by feces sampling for research at baseline and at week 24.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Finland

Pihlajalinna Ite, Satucon OY

Kuopio, Finland, 70100

Sweden

Clinical Trial Consultants

Uppsala, Uppland, Sweden, 752 37

Sponsors and Collaborators

Sigrid Therapeutics AB

Investigators

• Study Chair: Kirsi Pietiläinen, Prof.; Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki

More Information

Additional Information:

Information about the site and study in Kuopio, Finland 

Information about the site and study in Uppsala, Sweden 

• Responsible Party: Sigrid Therapeutics AB
• ClinicalTrials.gov Identifier: NCT03823027
• Other Study ID Numbers: STAR01
• First Posted: January 30, 2019
• Last Update Posted: November 5, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sigrid Therapeutics AB:

Medical Device; Prediabetes; Type2 Diabetes; Silica; Metabolic risk factors

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance; Overweight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Hyperglycemia