Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2017-06-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: ABO-GLYC
Libramed
ABO-GLYC
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
Group B: Placebo
ABO-GLYC Placebo
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
Interventions
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ABO-GLYC
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
ABO-GLYC Placebo
3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HbA1c at screening between 6.5% and 7.5%
3. Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
4. Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
5. BMI 25-38 kg/m2
6. Willing and able to understand and sign the informed consent and complete the patient diary provided
7. 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
2. Chronic gastro-intestinal disease
3. Heavy smoker subjects
4. Alcohol abuse
5. Chronic liver and kidney disease (AST or ALT values \> 2.5 UNL or plasma creatinine \> 1.5 mg/dl)
6. Previous major gastrointestinal surgery
7. History of eating disorders
8. Pregnancy or lactation
9. 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.
10. Autoimmune diseases
11. Known hypersensitivity to any of the components of the product.
12. Any condition which prevent subject participation in the opinion of the principal investigator.
18 Years
75 Years
ALL
No
Sponsors
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Latis S.r.l.
INDUSTRY
Fondazione Edmund Mach
OTHER
Aboca Spa Societa' Agricola
INDUSTRY
Responsible Party
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Locations
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Azienda Ospedaliera Padova
Padua, , Italy
Countries
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Other Identifiers
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ABO-GLYC-16
Identifier Type: -
Identifier Source: org_study_id
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