The standard of care for persons with prediabetes is lifestyle intervention, however in real-life less than 20% of people are able to adopt a healthier living. There is an unmet need for safe and effective treatment options for persons with prediabetes.
We have developed unique mesoporous silica particles (MSP) with tailored characteristics (SiPore15) that sequesters pancreatic amylase and lipase locally in the gut, resulting in decreased digestion of carbohydrates and fats. A first-in-man safety-trial in healthy and obese volunteers (clinicaltrials.org ID no. NCT03667430) showed a good safety profile for SiPore15 and an exploratory analysis revealed a reduction in HbA1c.
In the present efficacy-trial 43 subjects were enrolled, 33 persons with prediabetes (HbA1c 39 mmol/mol or above) and 10 persons newly diagnosed with diabetes type 2. All subjects were treated with SiPore15, 3 gm-TID with meals, for 12 weeks (clinicaltrials.org ID no. NCT03823027). A manufacturing error resulted in 26 subjects receiving the correct MSP for half of the treatment period and 9 subjects for the full period. An exploratory analysis revealed that the long-term blood glucose marker HbA1c was statistically reduced after 6 weeks (1 mmol/mol) and further reduced at 12 weeks (1.4 mmol/mol). Among the subjects who received the correct material, 0 subjects had a serious AE and the AEs reported were mild to moderate, indicating a favorable safety profile. The magnitude in HbA1c reduction was comparable to what has been observed with metformin in prediabetic clinical trials, translating to significant risk reduction in developing diabetes type 2.
SiPore15’s novel ingestible device concept, combined with the preliminary demonstration of efficacy and safety indicates that SiPore15 is an exciting approach for prevention and treatment of diabetes and merits further clinical investigation.
E.V. Johnston: None. M.N. Iqbal: None. G. Robert-Nicoud: Employee; Self; Sigrid Therapeutics. M.Z. Lindgren: None. E.R. Waara: None. A. Udden: None. K. Pietiläinen: None. T. Bengtsson: Board Member; Self; Atrogi, Sigrid Therapeutics.