Akturk: MannKind Abstract #813 for EASD Berlin 2018
Sept 6, 2018 6:20:39 GMT -5
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Session: Faster acting insulins: state of the art
Berlin 2018
Poster Halls
02-10-2018 13:15 - 14:15
Abstract # 813
Improved post-prandial blood glucose excursions with Technosphere inhaled insulin compared to aspart in adult patients with type 1 diabetes: STAT study intention to treat analysis
H.K. Akturk1, J.K. Snell-Bergeon1, E.A. Beck1, L.J. Klaff2, B. Bode3, A. Peters4, T.S. Bailey5, S.K. Garg1;
1University of Colorado, Aurora, 2Rainier Clinical Research Center, Renton, 3Atlanta Diabetes Associates, Atlanta, 4USC Westside Center for Diabetes, Beverly Hills, 5AMCR Clinic, Escondido, USA.
Background and aims: Post-prandial hyperglycemia remains a significant clinical concern; in great part due to the lack of very rapidly acting prandial insulin therapy. Over the past 2 decades, multiple efforts resulted in the development of faster-acting insulin analogs and inhaled insulin for use in clinical care. In this investigator-led, collaborative open-label randomized pilot clinical trial we evaluated the efficacy of Technosphere Insulin (TI) for lowering post-prandial blood glucose (PPBG) and post-prandial glucose excursion (PPGE) in a 4-week treatment period.
Materials and methods: Sixty patients with T1D on multiple daily injections were randomized in a multi-center study, stratified by A1c values (≤8% or >8%) to the control arm using aspart (n=34) vs TI group (n=26). Two patients in the TI arm discontinued from the study, and 2 had inadequate CGM data for analysis. Patients in the TI arm were instructed per protocol to take insulin doses pre-meal, and at 1 and 2 hours after meals based on observed PPBG values. Compliance with TI use was based on using TI per protocol pre-meal and at 1- and 2-hours post-meal, based on PPBG measures. Patients with at least 80% compliance were included in the TI-compliant per protocol group (n=15), and seven TI patients were evaluated in the per protocol non-compliant group. Baseline characteristics of the study group were compared to the randomization group using a student’s t-test, and CGM data from the study group was analyzed using linear regression models. Primary outcomes were CGM glucose percentage time in range (70-180 mg/dL) and PPGE 1-4 hours after meals.
Results: Groups had similar baseline characteristics, including age, sex, HbA1c, bolus insulin dose, and FEV1. Mean CGM glucose, glycemic variability (glucose SD/CV), time in range (70-180 mg/dL), and time in hyper- (>180 mg/dL) or hypoglycemia (<70, <60, or <50 mg/dL) were similar between groups. PPGE was significantly lower in the TI group than in the aspart group (Figure). The PPBG at 1 hour was lower in the TI group (mean ± SE PPBG difference -31.7±6.6 mg/dL, p<0.0001) and was numerically lower at 2 hours (mean ± SE PPBG -13.0±7.1 mg/dL, p=0.07) with no difference at 3 and 4 hours. The TI group increased their bolus insulin dose to mean ± SD of 47.8 ± 23.9 U/day compared to the aspart group (mean ± SD =23.0 ± 9.8 U/day; p<0.0001) during the initial week of the study. There was no difference
in HbA1c by study group at either screening or at the study end.
Conclusion: This data demonstrates that Technosphere Insulin when administered at meal time and supplemented (if needed) at appropriate post-meal intervals, significantly improved PPBG at 1- and 2- hours after meals and decreased PPGE when compared with insulin aspart in adult patients with T1D using MDI.
Clinical Trial Registration Number: NCT03143816
Supported by: Mannkind Corp.
Disclosure: H.K. Akturk: Grants; Mannkind Co.
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Berlin 2018
Poster Halls
02-10-2018 13:15 - 14:15
Abstract # 813
Improved post-prandial blood glucose excursions with Technosphere inhaled insulin compared to aspart in adult patients with type 1 diabetes: STAT study intention to treat analysis
H.K. Akturk1, J.K. Snell-Bergeon1, E.A. Beck1, L.J. Klaff2, B. Bode3, A. Peters4, T.S. Bailey5, S.K. Garg1;
1University of Colorado, Aurora, 2Rainier Clinical Research Center, Renton, 3Atlanta Diabetes Associates, Atlanta, 4USC Westside Center for Diabetes, Beverly Hills, 5AMCR Clinic, Escondido, USA.
Background and aims: Post-prandial hyperglycemia remains a significant clinical concern; in great part due to the lack of very rapidly acting prandial insulin therapy. Over the past 2 decades, multiple efforts resulted in the development of faster-acting insulin analogs and inhaled insulin for use in clinical care. In this investigator-led, collaborative open-label randomized pilot clinical trial we evaluated the efficacy of Technosphere Insulin (TI) for lowering post-prandial blood glucose (PPBG) and post-prandial glucose excursion (PPGE) in a 4-week treatment period.
Materials and methods: Sixty patients with T1D on multiple daily injections were randomized in a multi-center study, stratified by A1c values (≤8% or >8%) to the control arm using aspart (n=34) vs TI group (n=26). Two patients in the TI arm discontinued from the study, and 2 had inadequate CGM data for analysis. Patients in the TI arm were instructed per protocol to take insulin doses pre-meal, and at 1 and 2 hours after meals based on observed PPBG values. Compliance with TI use was based on using TI per protocol pre-meal and at 1- and 2-hours post-meal, based on PPBG measures. Patients with at least 80% compliance were included in the TI-compliant per protocol group (n=15), and seven TI patients were evaluated in the per protocol non-compliant group. Baseline characteristics of the study group were compared to the randomization group using a student’s t-test, and CGM data from the study group was analyzed using linear regression models. Primary outcomes were CGM glucose percentage time in range (70-180 mg/dL) and PPGE 1-4 hours after meals.
Results: Groups had similar baseline characteristics, including age, sex, HbA1c, bolus insulin dose, and FEV1. Mean CGM glucose, glycemic variability (glucose SD/CV), time in range (70-180 mg/dL), and time in hyper- (>180 mg/dL) or hypoglycemia (<70, <60, or <50 mg/dL) were similar between groups. PPGE was significantly lower in the TI group than in the aspart group (Figure). The PPBG at 1 hour was lower in the TI group (mean ± SE PPBG difference -31.7±6.6 mg/dL, p<0.0001) and was numerically lower at 2 hours (mean ± SE PPBG -13.0±7.1 mg/dL, p=0.07) with no difference at 3 and 4 hours. The TI group increased their bolus insulin dose to mean ± SD of 47.8 ± 23.9 U/day compared to the aspart group (mean ± SD =23.0 ± 9.8 U/day; p<0.0001) during the initial week of the study. There was no difference
in HbA1c by study group at either screening or at the study end.
Conclusion: This data demonstrates that Technosphere Insulin when administered at meal time and supplemented (if needed) at appropriate post-meal intervals, significantly improved PPBG at 1- and 2- hours after meals and decreased PPGE when compared with insulin aspart in adult patients with T1D using MDI.
Clinical Trial Registration Number: NCT03143816
Supported by: Mannkind Corp.
Disclosure: H.K. Akturk: Grants; Mannkind Co.
easddistribute.m-anage.com/from.storage?image=4iBH9mRQm1kfeEHULC2CxoXyiiFRjEN8yzAwOStli6AVhLMkbVQ3fpwygOwycnZNBBuLGI3e5FQt31yfTgy2oA2
