Type2 DiabetesNCT03568409
ABO-GLYC in Type 2 Diabetes
A study testing ABO-GLYC in people with Type2 Diabetes, run by Aboca Spa Societa' Agricola at 1 site in Italy.
Trial summary
Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- ABO-GLYC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 31 Dec 2021
- 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
- Male and female patients with diagnosis of type 2 diabetes, aged 18-75
- HbA1c at screening between 6.5% and 7.5%
- Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
- Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
- BMI 25-38 kg/m2
- Willing and able to understand and sign the informed consent and complete the patient diary provided
- Women participant of childbearing age should be negative to pregnancy test (performed on blood), and will have to use an appropriate contraceptive method throughout the study.
Who cannot join
- Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI)
- Chronic gastro-intestinal disease
- Heavy smoker subjects
- Alcohol abuse
- Chronic liver and kidney disease (AST or ALT values > 2.5 UNL or plasma creatinine > 1.5 mg/dl)
- Previous major gastrointestinal surgery
Show all 12Show fewer
- History of eating disorders
- Pregnancy or lactation
- Use of food supplements containing in particular but not limited to fibers and polysaccharides, in the last six months with frequency and dosage such as to interfere with the study.
- Autoimmune diseases
- Known hypersensitivity to any of the components of the product.
- Any condition which prevent subject participation in the opinion of the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes
Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
- Conditions
- Type2 Diabetes
- Being tested
- ABO-GLYC, ABO-GLYC Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO-GLYCDevice
Also called Libramed
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
ABO-GLYC PlaceboOther
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ABO-GLYC | Experimental | Libramed Receives: Device: ABO-GLYC |
| Group B: Placebo | Placebo comparator | Not described Receives: Other: ABO-GLYC Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
HbA1c measure
Measured: Week0 and Week24
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Tmax
Measured: Week0 and Week24
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Cmax
Measured: Week0 and Week24
Secondary outcomes (17)
Improvement of markers of glycemic variability (plasma glucose level)
Composite measurement of standard deviation and coefficient of variation of the plasma glucose level
Measured: Week0 to Week24
Improvement of markers of glycemic variability (MAGE)
mean amplitude of glucose excursion (MAGE)
Measured: Week0 to Week24
Improvement of markers of glycemic variability (HBGl)
high blood glycemic index (HBGI)
Measured: Week0 to Week24
Improvement of markers of glycemic variability (LBGI)
, low blood glycemic index (LBGI)
Measured: Week0 to Week24
Improvement of markers of glycemic variability (hypo/hyper glycemia)
percentage of time spent in hypoglycemia or hyperglycemia
Measured: Week0 to Week24
Improvement of markers of metabolic status (BMI)
Weight and height will be combined to report BMI in kg/m^2,total cholesterol, LDL triglycerides or NEFA, HDL and in the percentage of body fat determined by bioimpedentiometry
Measured: Week0 to Week24
Improvement of markers of glyco-oxidative stress
Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL
Measured: Week0 to Week24
Improvement of markers of inflammation
Measurement of TNF-alpha, IL-1, IL-6
Measured: Week0 to Week24
Improvement of markers of metabolic status (lipid profile)
Measurement of total cholesterol, HDL cholesterol and Tryglycerides
Measured: Week0 to Week24
Improvement of markers of metabolic status (body composition)
percentage of body fat determined by bioimpedentiometry
Measured: Week0 to Week24
Evaluation of gut microbiome changes (bacteria population)
Evaluation of bacteria population
Measured: Week 0, Week 1, Week 12, Week 24
Evaluation of gut microbiome changes (SCFA)
Evaluation of short change fatty acids measurements (SCFA)
Measured: Week 0, Week 1, Week 12, Week 24
Improvement in markers of insulin resistance
Measurement of HOMA-IR and QUICKI
Measured: Week 0 and Week 24
Improvement in markers of insulin secretion after standardized meal.
Measurement of insulin and c-peptide secretion measured during the glycemic curve after a standardized meal
Measured: Week 0 and Week 24
Evaluation of the dietary adherence
Perceived Dietary Adherence Questionnaire (PDAQ). The PDAQ uses a 5-point Likert scale to assess perceived difficulty.
Measured: Week0 to Week24
Adverse events (AEs) evaluation and product tolerability.
Adverse event will be recorded during the course of the study, after the signature of the informed consent
Measured: Week0 to Week24
Control of the glycemia.
The data from the glycemic diary will be monitored to assess the good control of the glycemia as measured by Self Monitoring of Blood Glucose (SMBG).
Measured: Week0 to Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jun 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l., Fondazione Edmund Mach
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568409
- Sponsor's protocol ID
- ABO-GLYC-16
- Status last verified
- Jul 2021
- First submitted
- 15 May 2018
- Last updated
- 30 Jun 2022
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03568409
- Acronym / sponsor ID
- ABO-GLYC-16
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l., Fondazione Edmund Mach
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jun 2018 (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.
Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ABO-GLYC | Experimental | Device: ABO-GLYCLibramed |
| Group B: Placebo | Placebo comparator | Other: ABO-GLYC Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients with diagnosis of type 2 diabetes, aged 18-75
- HbA1c at screening between 6.5% and 7.5%
- Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
- Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
- BMI 25-38 kg/m2
Key exclusion criteria (12 listed)
- Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI)
- Chronic gastro-intestinal disease
- Heavy smoker subjects
- Alcohol abuse
- Chronic liver and kidney disease (AST or ALT values > 2.5 UNL or plasma creatinine > 1.5 mg/dl)
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 |
|---|---|---|
| ABO-GLYCAlso: Libramed3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks. | Device | Group A: ABO-GLYC |
| ABO-GLYC Placebo3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks. | Other | Group B: Placebo |
Primary outcome
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Time frame: Week0 and Week24
HbA1c measure
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Time frame: Week0 and Week24
Tmax
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.
Time frame: Week0 and Week24
Cmax
17 secondary outcomes
Improvement of markers of glycemic variability (plasma glucose level)
Time frame: Week0 to Week24
Improvement of markers of glycemic variability (MAGE)
Time frame: Week0 to Week24
Improvement of markers of glycemic variability (HBGl)
Time frame: Week0 to Week24
Improvement of markers of glycemic variability (LBGI)
Time frame: Week0 to Week24
Improvement of markers of glycemic variability (hypo/hyper glycemia)
Time frame: Week0 to Week24
Improvement of markers of metabolic status (BMI)
Time frame: Week0 to Week24
Improvement of markers of glyco-oxidative stress
Time frame: Week0 to Week24
Improvement of markers of inflammation
Time frame: Week0 to Week24
Improvement of markers of metabolic status (lipid profile)
Time frame: Week0 to Week24
Improvement of markers of metabolic status (body composition)
Time frame: Week0 to Week24
Evaluation of gut microbiome changes (bacteria population)
Time frame: Week 0, Week 1, Week 12, Week 24
Evaluation of gut microbiome changes (SCFA)
Time frame: Week 0, Week 1, Week 12, Week 24
Improvement in markers of insulin resistance
Time frame: Week 0 and Week 24
Improvement in markers of insulin secretion after standardized meal.
Time frame: Week 0 and Week 24
Evaluation of the dietary adherence
Time frame: Week0 to Week24
Adverse events (AEs) evaluation and product tolerability.
Time frame: Week0 to Week24
Control of the glycemia.
Time frame: Week0 to Week24
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 30 Jun 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABO-GLYC in people with Type2 Diabetes, run by Aboca Spa Societa' Agricola at 1 site in Italy.
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 7 inclusion and 12 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 30 Jun 2022. 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 Italy. 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?
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?
Improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak. (time frame: Week0 and Week24). 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 30 Jun 2022.