Diabetes mellitus MedDRA version: 7.1 Level: PT Classification code 10012601
Conditions
Interventions
Product Name: Technosphere®/Insulin
Product Code: N/A
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Human Insulin rDNA
CAS Number: 11061-68-0
Current Sponsor code: N/A
Other descriptive
Sponsors
Mannkind Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects must meet all of the following inclusion criteria: Non-asthmatic Subjects: - Clinical diagnosis of type 2 diabetes mellitus. - Current basal and prandial insulin therapy for at least 6 weeks either as monotherapy or in combination with = 2 oral anti-hyperglycemic agents. - HbA1c = 12% at screening. Asthmatic Subjects: - Clinical diagnosis of type 2 diabetes mellitus. - Clinical diagnosis and confirmation of asthma (NAEPP Step 1-3) for at least one year - Current basal and prandial insulin therapy for at least 6 weeks either as monotherapy or in combination with = 2 oral anti-hyperglycemic agents. - FEV1/FVC = Predicted Lower Limit of Normal - HbA1c = 12% at screening. 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: Subjects presenting with any of the following will be excluded from the study: - Diabetes mellitus type 1. - Total daily insulin requirement of = 1.4U/kg. - Allergy to insulin or to any drugs to be used as part of the clinical trial, or history of hypersensitivity to the study drug or to drugs with similar chemical structures. - Clinical diagnosis and confirmation of Step 4 asthma. - Treatment with any investigational drug within 90 days prior to enrollment or during this study. - Previous history of anaphylaxis or angioedema. - Positive hepatitis B (HbsAg) HIV serology or active Hepatitis C (Hep C Ab) at screening. - Presence of pulmonary disease other than asthma (history of chronic obstructive pulmonary disease,chronic bronchitis, emphysema, occupational reactive airway disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate pulmonary lung function measured via serial spirometry after inhalation of Technosphere®/Insulin of non-asthmatic subjects with type 2 diabetes compared to asthmatic subjects with type 2 diabetes. 2. To evaluate the relative bioavailability and tolerability of plasma insulin following Technosphere®/Insulin administration in non-asthmatic subjects with type 2 diabetes compared to asthmatic subjects with type 2 diabetes. ;Secondary Objective: To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in asthmatic subjects with type 2 diabetes compared with non-asthmatic subjects with type 2 diabetes. ;Primary end point(s): The primary endpoint for the spirometry testing portion of the study is change in FVC and FEV1 among the two subjects groups. The primary parameters for the PK/PD part of the study are AUC PI (0-8 hours) and AUC GIR (0-8 hrs). | — |
Countries
Germany
Outcome results
None listed