Sponsor decision

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.

Objective(s): 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.

Research Plan: A randomized, prospective, double-blind study with randomization to lysulin and placebo in a 1:1 fashion. The study will enroll 60 patients with inadequately controlled type 2 diabetes.

Methods: The study will be performed as outpatient study at Phoenix VA Clinical Research Center. The study will include 3-4 visits. At the initial visit, participants will complete informed consent proc HbA1c ≥ 7.5 % and < 10%ess and undergo screening examination. Inclusion criteria will be age 21-75 years, HbA1c ≥ 7.5 % and < 10%, and stable dose of insulin 6 weeks prior to enrollment. Qualified participants will be randomized to 3,330 mg/day Lysulin (1,110 mg tbl, TID) as add-on supplement therapy for 12 weeks. Follow-up visits will be at weeks 6 and week 12 (end of study). Baseline and follow-up visits will include physical examination, patient history and blood draw. The primary study outcome measure will be fasting plasma glucose and HbA1c. Secondary outcome measures will include fasting plasma C-peptide and AGE concentrations. A linear mixed effects model will be used to evaluate treatment-induced endpoints. The models will be fit for sequential values of the response variable (including the baseline measurement).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Data will be available on request. To protect the privacy and confidentiality of the research subjects, data will be de-identified by stripping all 18 HIPAA identifiers as comma-delimited text (.csv) files to ensure it is impossible to back out any changes and recover identifiable information.

3 years