Hypoglycaemia is reduced with use of inhaled Technosphere® Insulin relative to insulin aspart in type 1 diabetes mellitus

E R Seaquist, L Blonde, J B McGill, S R Heller, D M Kendall, J B Bumpass, F M Pompilio, M L Grant, E R Seaquist, L Blonde, J B McGill, S R Heller, D M Kendall, J B Bumpass, F M Pompilio, M L Grant

Abstract

Aim: To evaluate the effect of final HbA1c levels on the incidences of hypoglycaemia in participants with type 1 diabetes treated with inhaled Technosphere® Insulin or subcutaneous insulin aspart, reported in alignment with the International Hypoglycaemia Study Group recommendations.

Methods: In the randomized, phase 3, multicentre AFFINITY-1 study, adults (N = 375) who had type 1 diabetes for ≥ 12 months and an HbA1c level of 58-86 mmol/mol (7.5-10.0%) were randomized to receive basal insulin plus either inhaled Technosphere Insulin or subcutaneous insulin aspart. This was a post-hoc regression analysis on a subset (N = 279) of the randomized AFFINITY-1 cohort for whom baseline and end-of-treatment HbA1c values were reported. Primary outcome measures were incidence and event rates for levels 1, 2 and 3 hypoglycaemia, respectively defined as blood glucose levels of ≤ 3.9 mmol/l, < 3.0 mmol/l or requiring external assistance for recovery.

Results: Participants treated with Technosphere Insulin experienced statistically significantly fewer level 1 and 2 hypoglycaemic events and a lower incidence of level 3 hypoglycaemia than participants treated with insulin aspart. The lower rate of hypoglycaemia with Technosphere Insulin was observed across the range of end-of-treatment HbA1c levels. Technosphere Insulin was associated with higher rates of hypoglycaemia 30-60 min after meals, but significantly lower rates 2-6 h after meals.

Conclusions: Participants using Technosphere Insulin experienced clinically non-inferior glycaemic control and lower hypoglycaemia rates across a range of HbA1c levels compared with participants receiving insulin aspart. ClinicalTrials.gov: NCT01445951.

© 2019 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Figures

Figure 1
Figure 1
Participant disposition. ANCOVA, analysis of covariance; MMRM, mixed‐effect model repeat measurement; TI, Technosphere® Insulin. aParticipants in the MedTone Inhaler group were not included in the original primary efficacy endpoint analysis of AFFINITY‐1 and were not included in this post‐hoc analysis.
Figure 2
Figure 2
Summary of level 1, level 2 and level 3 hypoglycaemia incidences and events after treatment with TI or insulin aspart. *P < 0.05. Pt, participant; TI, Technosphere® Insulin.
Figure 3
Figure 3
Hypoglycaemic event rates as a function of HbA1c. Distribution of (a) level 1, (b) level 2 and (c) level 3 hypoglycaemia events (rate per participant‐month) across the range of HbA1c values at the end of treatment with either TI or insulin aspart. Pt, participant; TI, Technosphere® Insulin.
Figure 4
Figure 4
Hypoglycaemia as a function of time after a meal for (a) level 1, (b) level 2, and (c) level 3 hypoglycaemia. *P < 0.05. TI, Technosphere® Insulin.

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Source: PubMed

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