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

Conditions: MedDRA version: 9.1Level: PTClassification code 10012601Term: Diabetes mellitus
Type 1 & Type 2 diabetes mellitus

Registration Number: EUCTR2007-002098-30-CZ

Lead Sponsor: MannKind Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures