Dataset Information

Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.

ABSTRACT:

Introduction

Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D).

Methods

Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17 years with T1D for more than 1 year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonary function testing criteria (at least 70% predicted). To assess PK, subjects received an individualized single preprandial dose of TI (4-12 U, in 4-U increments) via oral inhalation, based on their usual meal-time subcutaneously injected rapid-acting insulin dose and meal content. Serum insulin and blood glucose were measured at - 30 to 250 min relative to dosing.

Results

Twenty-seven children with T1D participated in this single-dose PK study. Mean subject age was 13.3 years (59% female; 81.5% White). Mean serum insulin C_max (maximum concentration) was 77.3, 119.15, and 207.7 µU/mL for doses of 4, 8, and 12 U, respectively. T_max occurred at 10.5, 13.9, and 14.6 min post-dose for 4, 8, and 12 U. Glucose lowering 30-60 min post-dose was consistent with the PK profile.

Conclusion

Serum insulin rapidly increased post-dose and returned to baseline by 120 min. The data suggests the PK of TI in youth with T1D ages 8-17 years was similar to that seen in previous adult studies.

Trial registration

ClinicalTrials.gov identifier, NCT02527265.

SUBMITTER: Haller MJ

PROVIDER: S-EPMC9981820 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.

Haller Michael J MJ Jones Marisa C MC Bhavsar Sunil S Kaiserman Kevin B KB

Diabetes therapy : research, treatment and education of diabetes and related disorders 20230118 3

<h4>Introduction</h4>Technosphere insulin (TI) is an inhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type 1 diabetes (T1D).<h4>Methods</h4>Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17 years with T1D for more than 1 year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonar ...[more]

PMID: 36652106

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Project description:BACKGROUND:The majority of therapies have generally targeted fasting glucose control, and current mealtime insulin therapies have longer time action profiles than that of endogenously secreted insulin. The primary purpose of this study was to assess both glucose time-in-range (TIR: 70-180?mg/dL) and postprandial glucose excursions (PPGE) in 1-4?h using a real-time continuous glucose monitor (CGM) with Technosphere insulin (TI) versus insulin aspart in patients with type 1 diabetes (T1DM) on multiple daily injections (MDI). RESEARCH DESIGN AND METHODS:This pilot, investigator-led, collaborative, open-label, multicenter, clinical research trial enrolled 60 patients with T1DM with HbA1c levels ?6.5% and ?10%. Individuals were randomized to treatment with titrated TI (n?=?26) or titrated insulin aspart (n?=?34), stratified by baseline HbA1c levels (?8% or >8%). All were required to wear a real-time CGM throughout the trial. All patients in the TI group were advised to take supplemental inhalations at 1 and 2?h after meals if indicated based on postprandial glucose (PPG) values. The coprimary outcomes were assessed both in the full intent-to-treat population and in those individuals randomized to TI who were compliant with supplemental doses ?90% of the time (n?=?15). The CGM data were analyzed using linear regression models. RESULTS:Overall, those treated with TI versus aspart achieved comparable TIR, but less time spent in hypoglycemia (<60 and <50?mg/dL, both P?<?0.05). In the TI-compliant group (n?=?15), TIR was significantly greater (62.5%?±?2.6% vs. 53.8%?±?1.7%, P?=?0.009) and time in hyperglycemia >180?mg/dL was lower (34.2%?±?2.7% vs. 41.0%?±?1.7%, P?=?0.045) as compared with the aspart group. PPG was also significantly lower in the TI cohort at 60 and 90?min postmeal, and PPGE were lower in the TI-compliant group as compared with the aspart group over 1-4-h postmeal (P?<?0.05). In addition, there was weight gain in the aspart group compared with weight loss in the TI group (P?=?0.006) despite higher prandial TI insulin dose. CONCLUSIONS:We conclude that using TI appropriately at mealtimes with supplemental dosing improves prandial glucose (TIR and 1-4?h) control without any increase in time in hypoglycemia or weight gain in patients with T1DM on MDI. The study results support a larger study using a treat-to-target design to confirm these findings. Clinical trial reg. no. NCT03143816, clinicaltrials.gov .

Dataset Information

Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.

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