PreDiabetesNCT03823027
STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
A study testing SiPore15™ in people with PreDiabetes and Pre Diabetes, run by Sigrid Therapeutics AB at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- PreDiabetes, Pre Diabetes, Prediabetic State
- What is being tested?
- SiPore15™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jan 2019to 2 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Male or female aged ≥18 years on the day of screening.
- Female subjects of childbearing potential must be on non-oral contraceptives, postmenopausal or sterile.
- 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).
- Body mass index (BMI) >25 kg/m2 and > or = 40 kg/m2.
- Stable weight for 3 months (+/-5 kg).
- No extreme changes in diet for the last 6 months such as anorexia, bulimia, etc.
- 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.
Who cannot join
- Diagnosed with type1 diabetes/Latent Autoimmune Diabetes in Adult (LADA) or secondary diabetes, as part of medical history or confirmed by laboratory test.
- Previous or current Metformin treatment or other glucose reducing drug therapy within 3 months before screening visit.
- Previous or current statin treatment or other blood lipid (LDL) reducing drug therapy, within 12 months before screening visit.
- 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.
- Subjects who stopped smoking within 6 months before screening visit.
- 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.
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- Any history of myocardial infarction or stroke within the 6 months before screening visit.
- 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.
- Pregnancy or breast feeding.
- Allergies to silicon dioxide.
- A diagnosed state that requires use of vitamin and/or mineral supplements during the study.
- Previous major gastric surgery that may affect the study outcome, such as bariatric surgery.
- 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.
- Ongoing or unstable liver condition that may cause changes in liver enzymes exceeding 2x upper normal levels.
- Psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
- History of or ongoing alcohol or drug addiction.
- Participation in any study involving an investigational drug or medical device within the past 30 days before the screening visit.
- 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).
- Is a relative of the Investigator or an employee at the clinical study site.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- SiPore15™
- Keywords
- Medical Device, Prediabetes, Type2 Diabetes, Silica, Metabolic risk factors
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiPore15™Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | 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. Receives: Device: SiPore15™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From week 1 to week 14
Secondary outcomes (2)
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).
Measured: 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).
Measured: From week 1 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start28 Jan 2019
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigrid Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsi Pietiläinen, Prof., Study chair, Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823027
- Sponsor's protocol ID
- STAR01
- Status last verified
- Nov 2019
- First submitted
- 28 Jan 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek J, Robert-Nicoud G, Herrera Hidalgo C, Borg ML, Iqbal MN, Berlin R, Lindgren M, Waara E, Udden A, Pietilainen 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.
PubMed 34854740
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03823027
- Acronym / sponsor ID
- STAR01
- Conditions
- PreDiabetes, Pre Diabetes, Prediabetic State, Type2 Diabetes, Type2 Diabetes Mellitus, Overweight
- Keywords
- Medical Device, Prediabetes, Type2 Diabetes, Silica, Metabolic risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sigrid Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: SiPore15™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. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form.
- Male or female aged ≥18 years on the day of screening.
- Female subjects of childbearing potential must be on non-oral contraceptives, postmenopausal or sterile.
- 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).
- Body mass index (BMI) >25 kg/m2 and > or = 40 kg/m2.
Key exclusion criteria (19 listed)
- Diagnosed with type1 diabetes/Latent Autoimmune Diabetes in Adult (LADA) or secondary diabetes, as part of medical history or confirmed by laboratory test.
- Previous or current Metformin treatment or other glucose reducing drug therapy within 3 months before screening visit.
- Previous or current statin treatment or other blood lipid (LDL) reducing drug therapy, within 12 months before screening visit.
- 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.
- Subjects who stopped smoking within 6 months before screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Single-arm |
Primary outcome
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.
2 secondary outcomes
Performance measured as changes in LDL-C
Time frame: From week 1 to week 12
Performance measured as changes in body fat %
Time frame: From week 1 to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 34854740Baek J, Robert-Nicoud G, Herrera Hidalgo C, Borg ML, Iqbal MN, Berlin R, Lindgren M, Waara E, Udden A, Pietilainen 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.
- Information about the site and study in Kuopio, FinlandLink provided by the sponsor.
- Information about the site and study in Uppsala, SwedenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi Pietiläinen, Prof. study chair
Gyllenberg Professor in Clinical Metabolism Obesity Research Unit University of Helsinki
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SiPore15™ in people with PreDiabetes and Pre Diabetes, run by Sigrid Therapeutics AB at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance measured as changes in HbA1c (time frame: From week 1 to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.