Status:
COMPLETED
STAR Study Investigating Performance and Safety of the Medical Device SiPore15™
Lead Sponsor:
Sigrid Therapeutics AB
Conditions:
PreDiabetes
Pre Diabetes
Eligibility:
All Genders
18-105 years
Phase:
NA
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 su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03823027
Start Date
January 28 2019
End Date
October 2 2019
Last Update
November 5 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pihlajalinna Ite, Satucon OY
Kuopio, Finland, 70100
2
Clinical Trial Consultants
Uppsala, Uppland, Sweden, 752 37