Evaluation of the Effect of Symptomatic Upper Respiratory Infections on Pharmacological Characteristics of Technosphere®/Insulin in Subjects with Diabetes Mellitus after a Meal Challenge

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002098-30-CZ

Enrollment

Registered

2007-10-19

Start date

2007-12-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 & Type 2 diabetes mellitus MedDRA version: 9.1 Level: PT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: Technosphere®/Insulin Product Code: A10A Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: Insulin Human rDNA CAS Number: 11061-68-0 Other descriptive name: Insu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All subjects must be active participants in the MKC-TI-030 trial and randomized to treatment with T/I; and Clinical diagnosis of upper respiratory tract infection (URI) defined as a subject having at least 3 URI symptoms, as defined in Appendix A, within the 24 hours prior to clinic visit and/or on the day of clinic visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Prior participation in MKC-TI-112 trial; and Evidence by medical history, physical examination or laboratory findings, in the opinion of the PI, suggestive of acute bacterial infection, including but not limited to, purulent sputum production, purulent nasal/eye/ear discharge, chest exam abnormalities to auscultation or percussion, throat exudates, CXR findings of pneumonia (if clinically indicated).

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the pharmacokinetic profile of FDKP following dosing with T/I, evaluated by AUC0-4h of serum FDKP after a meal challenge during active symptomatic URI compared with post-resolution URI.;Primary end point(s): Pharmacokinetic Variable: Serum FDKP AUC0-4hr in diabetic subjects with active, symptomatic upper respiratory infection treated with T/I versus FDKP AUC0-4hr from the same subjects, treated with T/I, after resolution of respiratory infection symptons; the subjects will serve as their own controls.;Secondary Objective: To assess the pharmacokinetic profile of serum insulin following dosingwith T/I, evaluated by AUC0-4h of serum insulin, C-peptide after a meal challenge, and safety of T/I as measured by blood glucose levels after a meal challenge including Cmax and Cmin of blood glucose, clinically significant findings from vital signs and abbreviated physical examinations, and adverse effects, during active symptomatic URI, compared with post-resolution URI.	—

Measure

Time frame

Main Objective: To assess the pharmacokinetic profile of FDKP following dosing with T/I, evaluated by AUC0-4h of serum FDKP after a meal challenge during active symptomatic URI compared with post-resolution URI.;Primary end point(s): Pharmacokinetic Variable: Serum FDKP AUC0-4hr in diabetic subjects with active, symptomatic upper respiratory infection treated with T/I versus FDKP AUC0-4hr from the same subjects, treated with T/I, after resolution of respiratory infection symptons; the subjects will serve as their own controls.;Secondary Objective: To assess the pharmacokinetic profile of serum insulin following dosingwith T/I, evaluated by AUC0-4h of serum insulin, C-peptide after a meal challenge, and safety of T/I as measured by blood glucose levels after a meal challenge including Cmax and Cmin of blood glucose, clinically significant findings from vital signs and abbreviated physical examinations, and adverse effects, during active symptomatic URI, compared with post-resolution URI.

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Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026