PreDiabetesPhase 2NCT05803772
A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation in Subjects With a Pathological Oral Glucose Tolerance Test
A Phase 2 study testing APHD-012 and APH-012P in people with PreDiabetes and Glucose Tolerance Impaired, run by Aphaia Pharma US LLC at 3 sites in Slovakia.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PreDiabetes, Glucose Tolerance Impaired
- What is being tested?
- APHD-012 and APH-012P
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesSlovakia
- Study dates
- 31 Mar 2023to 12 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 - 70 years of age
- Fully vaccinated against SARS-CoV-2.
- Body mass index 25-35 kg/m2
- Subjects with an impaired glucose tolerance defined as: HbA1c values ≥5.7% and ≤ 6.4%, and/or, Impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance Test (OGTT)) with or without impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
- Stable body weight: gain or loss in body weight ≤ 5% body weight over last 3 months
- History of at least one unsuccessful effort of lifestyle modification to loose >5% of body weight, completed at least 3 months prior to screening. Subject may have been treated with either diet or exercise alone.
- Willingness to undergo screening and all study procedures and examinations (i.e., physical examinations and laboratory investigations before and after the treatment periods) and to wear a flash glucose monitoring device.
- Ability to comprehend subject information and willingness to sign the informed consent.
Who cannot join
- Evidence of type 2 diabetes defined by fasting plasma glucose ≥ 126 mg/dL; 2-hour OGTT glucose ≥ 200 mg/dL
- Type I diabetes mellitus
- HbA1c ≥ 6.5%
- History of proliferative retinopathy or maculopathy
- Active COVID-19 infection proven by antigen positive Covid Test
- Treatment with any medication for weight loss within the past 3 months before screening.
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- Prior or planned weight loss surgery for obesity
- Recent (within past 12 months) or planned endoscopic treatment for obesity.
- Proven history of bulimia or anorexia nervosa
- Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts)
- Treatment with injectable anti-diabetic medications in the last 3 months (e.g., GLP-1 receptor agonists, insulin)
- Treatment with dipeptidyl peptidase-4 inhibitors in the last 3 months
- Confirmed medical history of liver cirrhosis
- Positive test on Viral hepatitis (HbsAG, HCV)
- Positive test on Human immunodeficiency virus (HIV)
- Cholestatic disease
- Alcohol-related liver disease including alcoholic fatty liver, alcoholic hepatitis and alcoholic cirrhosis evidenced by confirmed history of alcohol use, abnormal liver function tests defined below, and complete blood count (CBC), and/or liver biopsy.
- Abnormal liver function tests:
- Transaminases: Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN); or Aspartate aminotransferase (AST) ≥ 3x ULN;
- or Alkaline phosphatase (ALK) ≥2.5 x ULN
- or Total bilirubin ≥2 x ULN
- Stage 4 hypertension (systolic blood pressure (SBP) ≥ 180, diastolic BP (DBP) ≥ 110)
- History or presence of any uncontrolled cardiovascular, pulmonary, hepatobiliary, renal, hematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, or malignant disease (except conditions accepted for inclusion) which the clinical investigator considers a disqualification for participation in the study.
- Prior or current treatment with drugs aimed to treat abnormal glucose homeostasis including oral antidiabetics, incretin analogues and/or insulin.
- History of uncontrolled illness (e.g. depression, psychosis) or behaviour that at the discretion of the investigator might confound the study results or pose additional risk in administering the study procedures.
- Illicit drug abuse
- Alcohol abuse
- Participation in another investigational drug/biologic or medical device study within 30 days of screening or will be enrolled in another investigational drug or medical device study or any study in which active subject participation is required outside normal hospital data collection during the course of the study.
- Failure to provide informed consent.
- Unwillingness or inability to comply with the study protocol or study-related procedures.
Trial locations and contacts
3 sites in 1 country.
Slovakia3 sites
ALIAN, s.r.o.
Bardejov
MEDISPEKTRUM s.r.o.
Bratislava
Cell-B s.r.o.
Levice, Slovenska, 93405
About this study
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)
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)).
Read the 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:
- 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)?
- 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.
- Conditions
- PreDiabetes, Glucose Tolerance Impaired
- Being tested
- APHD-012, APH-012P
- Keywords
- OGTT, Glucose Tolerance, Prediabetes
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APHD-012Drug
Also called Distal jejunal-release dextrose beads
Drug: APHD-012 Distal jejunal-release dextrose beads (Aphaia technology, AT)
APH-012PDrug
Also called Placebo
Distal jejunal-release placebo beads
| Study group | Role | What they receive |
|---|---|---|
| Active to Placebo Cross | Other | Participants will first receive a single dose of APHD-012 12 g daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APH-012P for 6 weeks (day 71-112). Receives: Drug: APHD-012; Drug: APH-012P |
| Placebo to Active Cross | Other | Participants will first receive a single dose of APH-012P daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APHD-012 12 g for 6 weeks (day 71-112). Receives: Drug: APHD-012; Drug: APH-012P |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1 to Day 42; Day 71 to Day 112
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Day 1 to Day 42; Day 71 to Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start31 Mar 2023
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aphaia Pharma US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803772
- Sponsor's protocol ID
- CAP2022-1
- Status last verified
- Oct 2024
- First submitted
- 24 Mar 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05803772
- Acronym / sponsor ID
- CAP2022-1
- Conditions
- PreDiabetes, Glucose Tolerance Impaired
- Keywords
- OGTT, Glucose Tolerance, Prediabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aphaia Pharma US LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active to Placebo Cross | Other | Drug: APHD-012, Drug: APH-012PParticipants will first receive a single dose of APHD-012 12 g daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APH-012P for 6 weeks (day 71-112). |
| Placebo to Active Cross | Other | Drug: APHD-012, Drug: APH-012PParticipants will first receive a single dose of APH-012P daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APHD-012 12 g for 6 weeks (day 71-112). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects 18 - 70 years of age
- Fully vaccinated against SARS-CoV-2.
- Body mass index 25-35 kg/m2
- Subjects with an impaired glucose tolerance defined as: HbA1c values ≥5.7% and ≤ 6.4%, and/or, Impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance Test (OGTT)) with or without impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
- Stable body weight: gain or loss in body weight ≤ 5% body weight over last 3 months
Key exclusion criteria (30 listed)
- Evidence of type 2 diabetes defined by fasting plasma glucose ≥ 126 mg/dL; 2-hour OGTT glucose ≥ 200 mg/dL
- Type I diabetes mellitus
- HbA1c ≥ 6.5%
- History of proliferative retinopathy or maculopathy
- Active COVID-19 infection proven by antigen positive Covid Test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APHD-012Also: Distal jejunal-release dextrose beadsDrug: APHD-012 Distal jejunal-release dextrose beads (Aphaia technology, AT) | Drug | Active to Placebo Cross, Placebo to Active Cross |
| APH-012PAlso: PlaceboDistal jejunal-release placebo beads | Drug | Active to Placebo Cross, Placebo to Active Cross |
Primary outcome
Change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples
Time frame: Day 1 to Day 42; Day 71 to Day 112
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).
3 secondary outcomes
Change from baseline in fasting plasma glucose concentrations
Time frame: Day 1 to Day 42; Day 71 to Day 112
Change from baseline in HOMA IR
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)
Time frame: Day 1 to Day 42; Day 71 to Day 112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APHD-012 and APH-012P in people with PreDiabetes and Glucose Tolerance Impaired, run by Aphaia Pharma US LLC at 3 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples (time frame: Day 1 to Day 42; Day 71 to Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.