STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
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|ClinicalTrials.gov Identifier: NCT03823027|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes Pre Diabetes Prediabetic State Type2 Diabetes Type2 Diabetes Mellitus Overweight Obese||Device: SiPore15™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|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|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
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.
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.
- 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).
- 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.
- 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).
- 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).
- Exploratory Endpoints on usability, biometry and research samples [ Time Frame: From week 1 to week 24 ]A number of endpoints will be measures such as device usability, biometry and feces analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823027
|Contact: Kirsi Pietiläinen, Prof.||+358 (0) 2941 firstname.lastname@example.org|
|Dr Sakari Nieminen||Recruiting|
|Contact: Laura Jääskeläinen, Nurse +358 40 774 1104 email@example.com|
|Study Chair:||Kirsi Pietiläinen, Prof.||Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki|