Insulin Analogue (Basal + Pre-Prandial Injection) vs. Human Insulin (Basal Injection + Prandial Oral Insulin (Generex Oral-lyn™) in Type-1 Diabetes Mellitus: A 372-Day Comparison
Abstract Number: 2026-PO
Authors: JAIME GUEVARA-AGUIRRE, MARCO GUEVARA-AGUIRRE, JEANNETTE SAAVEDRA, ARLAN ROSENBLOOM, GERALD BERNSTEIN, Quito, Ecuador, Gainesville, FL, Toronto, ON, Canada
Institutions: Gainesville, FL; Toronto, ON, Canada
Results: This report is of Phase-3 of a 585-day study at which over than 45,000 daily pre-meal glucose measurements, and 2-week Fructosamine (Fruc) and Glycated Hemoglobin (HbA1c) determinations were obtained. Stabilization Phase-1 and First Comparison Phase-2 results were previously reported.
Phase-3 Participants were 26 Type-1 DM subjects (17 males -M-; 9 Females -F-). Age 26.6(+/-11.9); Height 168(+/-0.1)M//156(+/-0.1)F; Weight 65.64(+/-8.5)M//56.8(+/-4.2)F; BMI 23.3M//23.5F; Duration of DM 9.22M//11.9F.
Briefly, 26 subjects were allocated to Two Cohorts of 13 subjects each for a 372-day Comparison. Control Cohort (CC) subjects received Basal Once a Day subcutaneous (s.c). glargine insulin-analogue and Pre-meal s.c. lispro insulin analogue. Treated Cohort (TC) subjects received Basal twice daily sc-isophane insulin (NPH) + Meal time Generex Oral-lyn™. During Phase-3, over 29,000 glucose readings were self-obtained by research subjects (pre-breakfast, pre-lunch and pre-dinner) (Mean-G), and downloaded every two weeks using an Accu-Check Software. HbA1c and Fruc determinations were performed every 2 weeks. Within-subject treatment differences were normally distributed. Frequencies of within-subject comparisons are: HbA1c (CC?TC 2; CC>TC 25); Fruc (CC?TC 1; CC>TC 26); Pre-prandial Glucose (CC?TC 4; CC>TC 23). For HbA1c, Fruc and mean pre-prandial glucose, the levels were significantly lower in TC cohort (P<0.001 regardless of whether parametric or non-parametric tests were employed). Due to space constraints data obtained at baseline, the first five 2-week evaluations, and study are shown in the table.
A regimen consisting of basal BID s.c. NPH and prandial orally-absorbed regular insulin (Generex Oral-lyn™) attained lower pre-meal glucose, HbA1c and Fru concentrations, than a regimen using basal and pre-prandial insulin analogue injections in Type-1 DM during a 372-day period.