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Cited by 43Diabetes Treatment and ManagementDiabetes Management and ResearchInhalation and Respiratory Drug Delivery

Inhaled Technosphere Insulin versus inhaled technosphere placebo in insulin-naïve subjects with type 2 diabetes inadequately controlled on oral antidiabetes agents

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Rosenstock, Julio, Franco, Denise, Korpachev, Vadym, Shumel, Brad, Ma, Yuhui, Baughman, Robert, Amin, Nikhil, McGill, Janet B. +1 more·2015·Diabetes Care
DOI 10.2337/dc15-0629
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Abstract

OBJECTIVE: To investigate the efficacy and safety of prandial Technosphere inhaled insulin (TI), an inhaled insulin with a distinct time action profile, in insulin-naïve type 2 diabetes (T2D) inadequately controlled on oral antidiabetes agents (OADs). RESEARCH DESIGN AND METHODS: Subjects with T2D with HbA1c levels ≥7.5% (58.5 mmol/mol) and ≤10.0% (86.0 mmol/mol) on metformin alone or two or more OADs were randomized to add-on prandial TI (n = 177) or prandial Technosphere inhaled placebo (TP) (n = 176) to their OAD regimen in this double-blind, placebo-controlled trial. Primary end point was change in HbA1c at 24 weeks. RESULTS: TI significantly reduced HbA1c by −0.8% (−9.0 mmol/mol) from a baseline of 8.3% (66.8 mmol/mol) compared with TP −0.4% (−4.6 mmol/mol) (treatment difference −0.4% [95% CI −0.57, −0.23]; P < 0.0001). More TI-treated subjects achieved an HbA1c ≤7.0% (53.0 mmol/mol) (38% vs. 19%; P = 0.0005). Mean fasting plasma glucose was similarly reduced in both groups. Postprandial hyperglycemia, based on 7-point glucose profiles, was effectively controlled by TI. Mean weight change was 0.5 kg for TI and −1.1 kg for the TP group (P < 0.0001). Mild, transient dry cough was the most common adverse event, occurring similarly in both groups (TI, 23.7%; TP, 19.9%) and led to discontinuation in only 1.1% of TI-treated and 3.4% of TP-treated subjects. There was a small decline in forced expiratory volume in 1 s in both groups, with a slightly larger decline in the group receiving TI (TI, −0.13 L; TP, −0.04 L). The difference resolved after treatment discontinuation. CONCLUSIONS: Prandial TI added to one or more OADs in inadequately controlled T2D is an effective treatment option. Mild, transient dry cough was the most common adverse event.

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  • Different concentrations of rapid-acting insulin analogue may be beneficial in some populations.

    “Different concentrations of the rapid-acting analogue may be beneficial in some populations.1083”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1083]

    The Research Design and Methods section describes 10- and 20-unit doses of inhaled Technosphere insulin, not different concentrations of a rapid-acting insulin analogue. The passage on rapid-acting analogues discusses their action and serum levels, but does not say that different concentrations benefit particular populations. I searched for concentrations, formulation strengths, doses, and population-specific benefits. (LLM, conf=0.76)

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Research works printed but not linked: 1

  1. [21]21. Miller MR, Hankinson J, Brusasco V, et al.; ATS/ERS Task Force. Standardisation of spirom- etry. Eur Respir J 2005;26:319-338

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Authors
Rosenstock, J., Franco, D., Korpachev, V., Shumel, B., Ma, Y., Baughman, R., Amin, N., McGill, J. B., & for the Affinity 2 Study Group
Affiliations
  • Medical City Dallas Hospital (US)
  • CPCLIN Clinical Research Center, São Paulo, Brazil
  • V.P. Komisarenko Institute of Endocrinology and Metabolism (UA)
  • Regeneron (United States) (US)
  • MannKind Corporation (United States) (US)
  • Washington University in St. Louis (US)
Corresponding author
Rosenstock, Julio
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2015-08-07
Volume
38
Issue
12
Pages
2274-2281
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc15-0629
OpenAlex
W1760782438
Cited by
43
References
36
Citations by year
2026: 8 · 2025: 3 · 2023: 3 · 2022: 6 · 2021: 2 · 2020: 6 · 2019: 1 · 2018: 3 · 2017: 1 · 2016: 6 · 2015: 4
FWCI
4.05
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/site/license (vor, 299 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
Funders
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 › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
Keywords
prandial insulin, type 2 diabetes, insulin-naive patients, inadequate glycemic control, HbA1c, postprandial hyperglycemia, dry cough, forced expiratory volume, weight change, metformin, adverse events
MeSH terms
Administration, Inhalation, Adult, Aged, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Metformin, Microspheres, Middle Aged, Placebos, Powders, Treatment Outcome, Insulin, Regular, Human

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