MedTrace Logo

The Effect of Lysulin on Glycemic Control and Advanced Glycation

NCT04234581 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-10-19

No results posted yet for this study

Summary

The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lysulin

Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.

Sponsors & Collaborators

  • Juraj Koska

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234581 on ClinicalTrials.gov