The Effect of Lysulin on Glycemic Control and Advanced Glycation
Stopped early · Not applicable · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT04234581
- Run by
- Juraj Koska
- People needed
- 59
- Starts
- 2019-08-13
- Expected to finish
- 2020-06-12
- Last updated by the study team
- 2020-10-19
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 2 diabetes mellitus
- HbA1c ≥7.5% and <10.0% within past 6 weeks on diet only or stable doses of oral antihyperglycemic agents with or without insulin
- stable body weight (< 5% change in last 3 months)
- If on insulin therapy: < 20% variation in insulin units 6 weeks prior to the study.
You may not qualify if…
- Type 1 DM
- current or recent use of supplements containing lysine, zinc or vitamin C
- uncontrolled hypertension (blood pressure ≥160/90 mmHg)
- kidney disease (serum creatinine GFR ≤50 mL/min)
- major illness
- severe gastrointestinal disease
- pregnancy
- liver function tests > 2.5 times normal values in the past 3 months
- currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications
Where it is running
- Phoenix VA Healthcare System — Phoenix, Arizona, United States
- Phoenix VA Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.