Diabetes in AdolescenceNCT05994586
The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism
A study testing AP029 mix in people with Diabetes in Adolescence and PreDiabetes, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial summary
The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes in Adolescence, PreDiabetes
- What is being tested?
- AP029 mix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 25 May 2023to 26 Nov 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men, 18-75 years old
- Patients diagnosed with type II diabetes mellitus
- Patients on metformin treatment up to 5 months
- BMI 20-35 kg/m2
- Signed informed consent
- Women and men, 18-75 years old
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- BMI 20-35 kg/m2
- Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l)
- Signed informed consent
Who cannot join
- Patients diagnosed with type I diabetes
- Patients receiving insulin or other anti-diabetic medications
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding
- Surgery within the last 6 months
- Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins
- Intake of supplements containing: white mulberry, chromium, berberine
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- Patients receiving glucocorticosteroids, immunosuppressants
- Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant
- Acute inflammation (C-reactive protein >20mg/dl)
- Patients diagnosed with type I, II, LADA diabetes
- Patients receiving insulin or other anti-diabetic medications
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding
- Surgery within the last 6 months
- Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins
- Intake of supplements containing: white mulberry, chromium, berberine
- Patients receiving glucocorticosteroids, immunosuppressants
- Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant
- Acute inflammation (C-reactive protein >20mg/dl)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, 81-820
Barbara Khaidakov, PhD, 798 210 651 ext. +48, barbara.khaidakov@aronpharma.pl
Dagmara Wiewiórkowska-Garczewska
About this study
Official title: The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism
The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.
Read the detailed description
Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 20 patients with type II diabetes and 2) group of 10 patients with prediabetes.
Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed: level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In addition, a questionnaire of symptoms associated with metformin intake will be conducted
- Conditions
- Diabetes in Adolescence, PreDiabetes
- Being tested
- AP029 mix, Placebo
- Keywords
- Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP029 mixDietary supplement
Polyphenol-rich plant extracts Twice a day
PlaceboOther
Twice a day
| Study group | Role | What they receive |
|---|---|---|
| AP029 mix - type II diabetes | Experimental | Patients with type II diabetes receiving metformin for up to 5 months Receives: Dietary Supplement: AP029 mix |
| AP029 mix - prediabetes | Experimental | Patients with pre-diabetic Receives: Dietary Supplement: AP029 mix |
| Placebo - type II diabetes | Placebo comparator | Patients with type II diabetes receiving metformin for up to 5 months Receives: Other: Placebo |
| Placebo - prediabetes | Placebo comparator | Patients with pre-diabetic Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
Comparison of glucose level
Measured: Baseline, 2 months, 3 months, 5 months
Insulin level
Comparison of insulin level
Measured: Baseline, 2 months, 3 months, 5 months
Discomfort related to metformin side effects
Based on questionnaire
Measured: Baseline, 2 months, 3 months, 5 months
Secondary outcomes (3)
Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
Comparison of lipid panel markers
Measured: Baseline, 2 months, 3 months, 5 months
hsCRP level
Comparison of hsCRP level
Measured: Baseline, 2 months, 3 months, 5 months
HbA1c level
Comparison of hbA1c level
Measured: Baseline, 2 months, 3 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start25 May 2023
- Primary completion26 Nov 2023 (estimated)
- Study completion26 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in AdolescenceStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994586
- Sponsor's protocol ID
- 07-AP-MET
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism
- ClinicalTrials.gov ID
- NCT05994586
- Acronym / sponsor ID
- 07-AP-MET
- Conditions
- Diabetes in Adolescence, PreDiabetes
- Keywords
- Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- 26 Nov 2023 (estimated)
- Study completion
- 26 Nov 2023 (estimated)
- First posted
- 16 Aug 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 aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.
Detailed description
Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 20 patients with type II diabetes and 2) group of 10 patients with prediabetes.
Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed: level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In addition, a questionnaire of symptoms associated with metformin intake will be conducted
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AP029 mix - type II diabetes | Experimental | Dietary Supplement: AP029 mixPatients with type II diabetes receiving metformin for up to 5 months |
| AP029 mix - prediabetes | Experimental | Dietary Supplement: AP029 mixPatients with pre-diabetic |
| Placebo - type II diabetes | Placebo comparator | Other: PlaceboPatients with type II diabetes receiving metformin for up to 5 months |
| Placebo - prediabetes | Placebo comparator | Other: PlaceboPatients with pre-diabetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women and men, 18-75 years old
- Patients diagnosed with type II diabetes mellitus
- Patients on metformin treatment up to 5 months
- BMI 20-35 kg/m2
- Signed informed consent
Key exclusion criteria (18 listed)
- Patients diagnosed with type I diabetes
- Patients receiving insulin or other anti-diabetic medications
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding
- Surgery within the last 6 months
- Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins
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 |
|---|---|---|
| AP029 mixPolyphenol-rich plant extracts Twice a day | Dietary supplement | AP029 mix - prediabetes, AP029 mix - type II diabetes |
| PlaceboTwice a day | Other | Placebo - prediabetes, Placebo - type II diabetes |
Primary outcome
Glucose level
Time frame: Baseline, 2 months, 3 months, 5 months
Comparison of glucose level
Insulin level
Time frame: Baseline, 2 months, 3 months, 5 months
Comparison of insulin level
Discomfort related to metformin side effects
Time frame: Baseline, 2 months, 3 months, 5 months
Based on questionnaire
3 secondary outcomes
Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)
Time frame: Baseline, 2 months, 3 months, 5 months
hsCRP level
Time frame: Baseline, 2 months, 3 months, 5 months
HbA1c level
Time frame: Baseline, 2 months, 3 months, 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- 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.
Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko
Sopot, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP029 mix in people with Diabetes in Adolescence and PreDiabetes, run by AronPharma Sp. z o. o. at 1 site in Poland.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose level (time frame: Baseline, 2 months, 3 months, 5 months). The study lists 3 primary outcomes in all. 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 Aug 2023.