Randomized, Double-blinded, Placebo-controlled, Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21® in Obese or Overweight Subjects With Elevated Blood Glucose Levels
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight or Obesity
- Sponsor
- Sigrid Therapeutics AB
- Enrollment
- 318
- Locations
- 27
- Primary Endpoint
- HbA1c level
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.
Detailed Description
The proposed investigation is set out to be a randomized, double blind, placebo-controlled, multicenter study according to MDR Article 62 to investigate performance and safety of the medical device SiPore21® in subjects with obesity or overweight and elevated blood glucose levels. The aim of this clinical investigation is to evaluate the clinical performance of the IMD for blood glucose control and its clinical safety. The endpoints selected to evaluate the effects of the IMD are based on the state-of-the-art assessments of blood glucose control (ADA, 2022). The main hypothesis is that treatment with SiPore21® for 12 weeks will reduce the HbA1c in obese or overweight subjects with elevated blood glucose levels. It is further hypothesized that treatment with SiPore21® for 12 weeks will result in a reduction in body weight and influence metabolic control parameters and lipid levels.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female 18-70 years old
- •HbA1c level ≥42 to 58 mmol/mol (≥6 to 7.5% - according to Diabetes Control and Complications Trial \[DCCT, 1987\]) at V1 For Poland only: HbA1c level ≥42 to 53 mmol/mol (≥6 to 7% - according to the Official Journal of the Diabetes Poland, 2023 Vol. 3 Issue 1) at V1
- •Body mass index (BMI) \>25 kg/m2 and 40 kg/m2
- •Regular intake of 3 main meals (self-reported)
- •Readiness and ability to:
- •use the study treatment as recommended and attend all scheduled visits
- •comply with all further study procedures
- •Readiness to maintain the current diet and level of physical activity during the study
- •Readiness not to participate in another clinical study during this study
- •Women of childbearing potential: commitment to use medically recognized contraception methods during the treatment period
Exclusion Criteria
- •Known allergy or hypersensitivity to the components of the IMD or placebo (self-reported)
- •Type 1 diabetes (T1D)/Latent Autoimmune Diabetes in Adult or secondary diabetes (self-reported)
- •Uncontrolled hypertension (regularly \>179/109 mmHg \[self-reported\] and as per investigator's judgement based on screening procedures at V1)
- •History (self-reported) of myocardial infarction or stroke 6 months prior to V1
- •Clinically relevant abnormal electrocardiogram (ECG) at V1
- •History (\<3 years prior to V1) or presence (self-reported) of:
- •exocrine pancreatic insufficiency, chronic pancreatitis
- •chronic inflammatory bowel disease, celiac disease
- •diverticulosis (usually affecting the large intestine), adhesions, chronic constipation
- •State after pancreatic head resection with the need for additional intake of pancreatic enzymes (self-reported)
Outcomes
Primary Outcomes
HbA1c level
Time Frame: Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
To evaluate if the IMD treatment leads to a greater reduction in HbA1c level (relative to baseline) in comparison to placebo, in obese or overweight subjects with elevated blood glucose levels.
Secondary Outcomes
- Body weight(Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.)