Evidence map›Paper›PMID 34773608›Full record

Trial reportClinical pharmacokinetics2022

Comparison of Pharmacokinetics and Pharmacodynamics of Inhaled Technosphere Insulin and Subcutaneous Insulin Lispro in the Treatment of Type 1 Diabetes Mellitus.

Marshall Grant, Tim Heise, Robert Baughman

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02470637 (A Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic Clamp Technique), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02470637 phase1completednot on this map

A Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic Clamp Technique

TypeinterventionalSponsorMannkind CorporationRan2015 to 2015Enrolled30ConditionsType 1 Diabetes MellitusArmsSAR439065, Insulin lispro
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 25 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. Safety and Efficacy of Inhaled TechnosphereDiabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  7. Article
  8. Article
  9. Review
  10. Revolutionizing Diabetes Care: From Tech to Therapeutics.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Article
  11. Prandial Insulins: A Person-Centered Choice.Current diabetes reports · 2024
    Review
  12. Article
  13. Review
  14. Time-Action Profile of Technosphere Insulin in Children with Type 1 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 2 countries.

Marshall GrantMannKind Corporation, 30930 Russell Ranch Rd, Suite 300, Westlake Village, CA, 91362, USA. mgrant@mannkindcorp.com.ORCID http://orcid.org/0000-0002-0022-6873
Tim HeiseProfil, Neuss, Germany.ORCID http://orcid.org/0000-0002-8346-2037
Robert BaughmanTakeda Pharmaceutical Company Ltd, Lexington, MA, USA.ORCID http://orcid.org/0000-0003-2752-9855
MannKind Corporation (United States) · USProfil Institute for Metabolic Research · DETakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study was performed to satisfy a US Food and Drug Administration post-marketing requirement to compare the dose responses for Technosphere

objectivesThis single-center, open-label, randomized, cross-over study defined the pharmacokinetic/pharmacodynamic curves for inhaled TI vs subcutaneous LIS in persons with type 1 diabetes mellitus.

methodsEach volunteer received six treatments while undergoing euglycemic clamps: three doses of TI (10, 30 and 120 U) and LIS (8, 30, and 90 U). Primary endpoint was area under the glucose infusion rate vs time curve from start of treatment administration to end of clamp. Key secondary endpoints included readouts of insulin exposure and timing of pharmacokinetic/pharmacodynamic profiles.

resultsInsulin exposure was more than dose proportional, increasing with dose

conclusionsTechnosphere Insulin has a considerably faster onset and shorter duration of action than LIS. Consequently, the overall effect of TI is smaller than that of LIS and unit-for-unit dose conversion is not appropriate. CLINICAL

trial registrationClinicalTrials.gov, NCT02470637; 12 June, 2015.

Indexed as

Diabetes Mellitus, Type 1InsulinBlood GlucoseCross-Over StudiesGlucoseHumansHypoglycemic AgentsInsulin LisproBlood GlucoseGlucoseHypoglycemic AgentsInsulinInsulin Lispro

Identifiers

PMID34773608
PMCPMC8891188
OpenAlexW3213041209

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.