ABO-GLYC in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of ABO-GLYC on Glycemic and Metabolic Status of Patients With Type 2 Diabetes

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Device: ABO-GLYC
* Other: ABO-GLYC Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: ABO-GLYC<br>Libramed | Device: ABO-GLYC<br>* 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.<br>* Other names: Libramed;|
| Placebo Comparator: Group B: Placebo<br> | Other: ABO-GLYC Placebo<br>* 3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Week0 and Week24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of markers of glycemic variability (plasma glucose level) | Composite measurement of standard deviation and coefficient of variation of the plasma glucose level | Week0 to Week24 | 
| Improvement of markers of glycemic variability (MAGE) | mean amplitude of glucose excursion (MAGE) | Week0 to Week24 | 
| Improvement of markers of glycemic variability (HBGl) | high blood glycemic index (HBGI) | Week0 to Week24 | 
| Improvement of markers of glycemic variability (LBGI) | , low blood glycemic index (LBGI) | Week0 to Week24 | 
| Improvement of markers of glycemic variability (hypo/hyper glycemia) | percentage of time spent in hypoglycemia or hyperglycemia | 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 | Week0 to Week24 | 
| Improvement of markers of glyco-oxidative stress | Measurement of receptor for advanced glycation endproducts (RAGE), Malondialdehyde (MDA) and/or oxidized LDL | Week0 to Week24 | 
| Improvement of markers of inflammation | Measurement of TNF-alpha, IL-1, IL-6 | Week0 to Week24 | 
| Improvement of markers of metabolic status (lipid profile) | Measurement of total cholesterol, HDL cholesterol and Tryglycerides | Week0 to Week24 | 
| Improvement of markers of metabolic status (body composition) | percentage of body fat determined by bioimpedentiometry | Week0 to Week24 | 
| Evaluation of gut microbiome changes (bacteria population) | Evaluation of bacteria population | Week 0, Week 1, Week 12, Week 24 | 
| Evaluation of gut microbiome changes (SCFA) | Evaluation of short change fatty acids measurements (SCFA) | Week 0, Week 1, Week 12, Week 24 | 
| Improvement in markers of insulin resistance | Measurement of HOMA-IR and QUICKI | 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 | 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. | 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 | 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). | Week0 to Week24 |