NCT03568409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 30, 2022

Status Verified

July 1, 2021

Enrollment Period

4.6 years

First QC Date

May 15, 2018

Last Update Submit

June 28, 2022

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (17)

  • Improvement of markers of glycemic variability (plasma glucose level)

    Week0 to Week24

  • Improvement of markers of glycemic variability (MAGE)

    Week0 to Week24

  • Improvement of markers of glycemic variability (HBGl)

    Week0 to Week24

  • Improvement of markers of glycemic variability (LBGI)

    Week0 to Week24

  • Improvement of markers of glycemic variability (hypo/hyper glycemia)

    Week0 to Week24

  • +12 more secondary outcomes

Study Arms (2)

Group A: ABO-GLYC

EXPERIMENTAL

Libramed

Device: ABO-GLYC

Group B: Placebo

PLACEBO COMPARATOR
Other: ABO-GLYC Placebo

Interventions

ABO-GLYCDEVICE

3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

Also known as: Libramed
Group A: ABO-GLYC
ABO-GLYC PlaceboOTHER

3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.

Group B: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Padova

Padua, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 26, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 30, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)