NCT03823027

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Sigrid Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 105 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes
• Pre Diabetes
• Prediabetic State
• Type2 Diabetes
• Type2 Diabetes Mellitus
• Overweight
• Obese

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-10-02
• Completion: 2019-10-02
• First posted: 2019-01-30
• Last updated: 2019-11-05

Locations

2 sites across 2 countries: Finland, Sweden