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)).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Cell-B s.r.o.
Levice, Slovenska, Slovakia
ALIAN, s.r.o.
Bardejov, Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, Slovakia
Change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples
The primary efficacy endpoint is the change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) measured in blood samples at the end of each study period (Day 42 and Day 112, respectively). Two baselines will be defined for each period separately (Day 1 and Day 71, respectively).
Time frame: Day 1 to Day 42; Day 71 to Day 112
Change from baseline in fasting plasma glucose concentrations
Change from baseline in fasting plasma glucose concentrations will be measured as ratio to baseline of fasting plasma glucose concentration at week 6 of each study period.
Time frame: Day 1 to Day 42; Day 71 to Day 112
Change from baseline in HOMA IR
Change from baseline in HOMA IR will be measured as ratio to baseline of HOMA-IR at week 6 of each study period
Time frame: Day 1 to Day 42; Day 71 to Day 112
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment
Time frame: Day 1 to Day 42; Day 71 to Day 112
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