A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation in Subjects With a Pathological Oral Glucose Tolerance Test
brief summary
The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in participants with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)).
detailed description
The goal of this Phase II, Randomized, Placebo-Controlled Crossover Proof-of-Concept Study is to evaluate the efficacy of APHD-012 in patients with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)). The main questions it aims to answer are:
1. Are there changes in baseline in Area Under the Curve from Time 0 to 2 Hours (AUC0-2) values of Oral Glucose Tolerance Test (OGTT)? 2. Are there changes in biomarkers (e.g. fasting plasma glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR))?
Participants will receive study medication or placebo once daily for 6 weeks, followed by washout period of 4 weeks, and subsequent crossover to the other treatment arm for 6 weeks.
official title
A Phase II, Randomized, Placebo - Controlled Crossover Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation (APHD-012) in Subjects With a Pathological Oral Glucose Tolerance Test (OGTT)