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Results of a 24-week trial of technosphere insulin versus insulin aspart in type 2 diabetes

Open access
Hoogwerf, Byron J., Pantalone, Kevin M., Basina, Marina, Jones, Marisa C., Grant, Marshall, Kendall, David M.·2021·Endocrine Practice
DOI 10.1016/j.eprac.2020.11.002
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Abstract

OBJECTIVE: To compare glycemic efficacy of Technosphere insulin (TI) versus that of insulin aspart (IA), each added to basal insulin, in type 2 diabetes. METHODS: This randomized, 24-week trial included subjects aged from 18 to 80 years who were treated with subcutaneous insulin for 3 months and had glycated hemoglobin (HbA1C) levels of 7.0% to 11.5%. After receiving stabilized insulin glargine doses during a 4-week lead in, the subjects were randomized to TI or IA. The primary end point was an HbA1C change from baseline, with the differences analyzed by equivalence analyses. RESULTS: , weight was 82.2 (13.6) kg, and duration of diabetes was 12.2 (7.1) years. An intention-to-treat cohort had 150 subjects randomized to TI (mean [SD] HbA1C: 8.9% [1.1%]) and 154 randomized to IA (mean [SD] HbA1C: 9.0% [1.3%]). At 24 weeks, mean (SD) HbA1C value declined to 7.9% (1.3%) and 7.7% (1.1%) in the TI and IA cohorts, respectively. A treatment difference of 0.26% was not statistically significant, but the predefined equivalency margin was not met. Subjects receiving TI lost 0.78 kg compared to baseline; subjects receiving IA gained 0.23 kg (P =.0007). The incidence of mild/moderate hypoglycemia was lower for the TI cohort, though not statistically significant. CONCLUSION: Both TI and IA resulted in significant and clinically meaningful HbA1C reductions. TI also resulted in significant and clinically meaningful weight reductions. These data support the use of inhaled insulin as a treatment option for individuals with type 2 diabetes.

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  • Inhaled insulin has faster onset and shorter duration compared with the rapid-acting insulin analog lispro.

    “Studies comparing inhaled insulin with injectable insulin have demonstrated its faster onset and shorter duration compared with the RAA insulin lispro as well as clinically meaningful A1C reductions and weight reductions compared with the RAA insulin aspart over 24 weeks (186-188).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [187]

    The Introduction says Technosphere inhaled insulin has a faster onset and shorter duration than subcutaneously injected rapid-acting insulin analogs. The paper does not identify lispro as the comparator; its 24-week trial compares Technosphere insulin with insulin aspart. Thus it supports the general pharmacologic comparison, but not the lispro-specific attribution. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • Inhaled insulin produces clinically meaningful A1C reductions compared with insulin aspart over 24 weeks.

    “Studies comparing inhaled insulin with injectable insulin have demonstrated its faster onset and shorter duration compared with the RAA insulin lispro as well as clinically meaningful A1C reductions and weight reductions compared with the RAA insulin aspart over 24 weeks (186-188).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [187]

  • Inhaled insulin produces weight reductions compared with insulin aspart over 24 weeks.

    “Studies comparing inhaled insulin with injectable insulin have demonstrated its faster onset and shorter duration compared with the RAA insulin lispro as well as clinically meaningful A1C reductions and weight reductions compared with the RAA insulin aspart over 24 weeks (186-188).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [187]

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Research works printed but not linked: 30

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Cited by

Sorted by citations

Authors
Hoogwerf, B. J., Pantalone, K. M., Basina, M., Jones, M. C., Grant, M., & Kendall, D. M.
Affiliations
  • Cleveland Clinic (US)
  • Stanford Medicine (US)
  • MannKind Corporation (United States) (US)
Corresponding author
Jones, Marisa C.
ORCID
Venue
Endocrine Practice
Publisher
Elsevier BV
Published
2021-01
Volume
27
Issue
1
Pages
38-43
ISSN
1530-891X (ISSN-L)
DOI
10.1016/j.eprac.2020.11.002
OpenAlex
W3117434712
Cited by
22
References
3
Citations by year
2026: 5 · 2025: 6 · 2024: 4 · 2023: 3 · 2022: 4
FWCI
1.32
Type
journal article
Language
en
Open access
Licence
Locations
  • Endocrine Practice (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
  • Bayer Fund
  • Merck
  • Novo Nordisk
  • Allergan
  • MannKind Corporation
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
Technosphere insulin, insulin aspart, type 2 diabetes, inhaled insulin, basal insulin, glycemic control, HbA1c, weight loss, hypoglycemia, insulin glargine
MeSH terms
Insulin Glargine, Adolescent, Adult, Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, Insulin, Long-Acting, Young Adult, Insulin Aspart

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