![]() For Group C, 65% of the subjects responded to Lysulin with a change of -1.64% A1c in 12 weeks and change of -1.91% in 26 weeks. At 12 weeks, the change in A1c for Group A was 0.03%, the change for Group B was -0.30% and the change for Group C was -0.97%. Changes in A1c were observed for some subjects in as little as 4 weeks after initiation of Lysulin supplementation. Results: The results revealed a statistically significant reduction in A1c in the two groups taking Lysulin (Group B p<0.02 and Group C p<0.004) as compared to the placebo group. The data will be presented as Average followed by Standard Deviation in parenthesis where appropriate. For observation purposes, Groups B and C were followed to 26 weeks. The primary endpoint of this pilot study changed in A1c from baseline to week 12. Subjects were evaluated at Baseline and at 4, 8 and 12 weeks. Subjects were randomized 1:1:1 into groups based on oral supplementation: Group A Placebo, Group B 2.22 g/day Lysulin Group, Group C 3.33 g/day Lysulin. Subjects of ages 49 (9) years with a range of 33-74 years and both sexes (31 women and 36 men) were included in the study. The inclusive range of low, medium and high in A1c levels was chosen to evaluate if there was a biased response to a specific A1c level. Subjects enrolled in the study had average an A1c 8.5 (2.2) and range 5.1%-12.9% at baseline. Methods: A randomized, double-blind placebo-controlled pilot study was conducted over a 12-week period in 67 subjects. This is a Pilot Study and it is intended to be used to design a further confirmatory clinical study by providing information on the feasibility of recruitment, randomization, sample size, retention, and assessment of procedures, methods and implementation of a novel intervention: Lysulin. Objective: This Pilot Study is aimed at evaluating the effect of daily oral supplementation with Lysulin ® on glycemic control as assessed by measurement of Hemoglobin A1c (A1c), cardiometabolic and anthropometric parameters as compared to Placebo in people with Type 2 diabetes. John F Burd * 1, Vivianne Noetzel 1, Adriana Gonzalez 1 and Francisco Alberto AlvarezĢ Saint John’s Medical Center, Tijuana, Baja California *Corresponding Author: John F Burd
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