Clinical dose-finding study to assess the effect of ABAlifeTM on postprandial blood glucose profile in prediabetic subjects: randomized, multicentric, double-blind, placebo-controlled, cross-over study with different dosages combined with a 12-weeks follow-up phase - BTS1462/19

Anton Hübner GmbH & Co. KG0 sites61 target enrollmentAugust 18, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 18, 2021

End Date

November 16, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Anton Hübner GmbH & Co. KG

•Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5\.7% and 6\.4% and/or fasting glucose \= 5\.6 mmol/L (\= 100 mg/dL) and \< 7\.0 mmol/L (\< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is \< 5\.7%)
•Body mass index 19\-35 kg/m2
•Current Non\-smoker
•Availability and presence in the study units for approx. 3\.5 hours/ week for 2 times (Visit 1 and Visit 2\) and approx. 4\.5 hours/ week for 2 times (Visit 3 and Visit 5\).
•Signed informed consent form
•No changes in food habits or physical activity 3 months prior to screening and during the study
•If applicable, stable intake of chronic medication of at least 4 weeks

•Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
•Presence of disease or drug(s) influencing digestion and absorption of nutrients
•Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT\-2 inhibitors, GLP\-1 receptor agonists, steroids, protease inhibitors or antipsychotics
•Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator’s opinion would impact patient safety
•Severe liver or renal disease (e.g. CKD stage \=4\) or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN)
•Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon\-cancer, rectum cancer, pancreatitis)
•Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
•Major medical or surgical event requiring hospitalization within the previous 3 months
•Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
•Intake of antibiotics within 4 weeks before the test days