SAT-LB028 Efficacy and Safety of Pramlintide as an Adjunct to Insulin U500 Therapy in Veterans with Severe Insulin Resistance

Background: Obese Type 2 diabetes(T2DM) patients with high insulin resistance may require insulin U500 therapy. There is a lack of safety and efficacy data for the use of Pramlintide (P) as an adjunct therapy with U500 insulin (U500I) to maintain optimal glucose control and effect on daily insulin requirement and weight. Methods: We performed a retrospective chart review of 111 obese, T2DM patients requiring U500 insulin. Two groups were identified using the pharmacy database from 2011-2016: U-500 insulin only: U5 Group (N=54), and U-500 insulin with pramlintide: U5P group (N=57). In each group, we assessed demographics (age, ethnicity, gender), comorbidities, A1c (0, 12 months), weight (0, 12 months), total daily dose of insulin (TDD) at 12 months, frequency of conversion to U100 insulin or to <150 units of U500I, and hypoglycemic events over 12 months. We assessed means (SD), frequencies (%) and Spearman’s correlations. Group comparisons conducted via Chi-square and ANOVA. Statistical significance at p<0.05. Results: The U5 group (N= 54) had 98% white males (94%) with mean age 57 years, and U5P group (N= 57) had 96% white males (94%) with mean age 55 years. There was no significant difference between the groups for CAD, HTN, CHF, CVA, PAD, CKD, and COPD. Differences in baseline A1C and weight between groups were statistically significant with baseline A1C 9.43% (1.44), weight 276.3 lbs. (42.8) in U5 group and HbA1c 8.26% (0.74) (p: <0.001), weight 296 lbs. (47.9) (p:0.02) in U5P group. No significant difference noted in TDDI (U5: 239.6 U (74.6), U5P: 243.3 (105.1), p: 0.91). At 12 months, an average 0.7% decline in A1c [8.73% (1.73)] in U5 group associated with a weight gain of 3.14 lbs. (13.59) along with an increase in TDDI (250.2U) by 12.20U (75.55), while U5P group had an increase in A1c [8.48% (1.24)] by 0.26%, and a weight loss of 5.06 lbs. (14.57) with a decline in TDDI by 9.61U (75.88) to 237.1U. When compared between the group, statistical significance noted in HbA1c improvement (p: 0.0003) in U5group and a decrease in weight (p: 0.002) in U5P group, and a non-statistically significant decline in TDDI noted in U5P group (p:0.35). Non-significant difference was noted in frequency of conversion to <150 units TDDI: 2% in U5 group and 4% in U5P group (p:0.53) and to U-100 insulin: 11% in U5 group and 13% in U5P group (p:0.69). Severe hypoglycemia frequency was also not statistically different: 26% in U5 group and 38% in U5P group (p: 0.19). Conclusions: For obese T2DM patients with severe insulin resistance requiring U500I, an adjunct therapy of pramlintide can assist in achieving stable control and weight loss. Our results show that with U500I therapy HbA1C improved however the U5 cohort started at a higher A1c with a decline of <1% with significant weight gain, while U5P cohort had a small increase in A1c with associated weight loss and reduction in insulin doses without any significant increase in hypoglycemia. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.