A Parallel, Open-label, Single Dose of Inhaled Technosphere®/Insulin Pulmonary Lung Function Study Followed by a Parallel Prospective, Controlled, Two-center, Euglycemic Clamp Procedure Before and After 7 Days Treatment with Technosphere®/Insulin Comparing Prandial Inhalation of Technosphere®/Insulin in Non-asthmatic Type 2 Diabetes Subjects with Asthmatic Type 2 Diabetes Subjects - N/A

• Conditions: Diabetes mellitus; MedDRA version: 7.1Level: PTClassification code 10012601

• Registration Number: EUCTR2005-001884-80-DE
• Lead Sponsor: Mannkind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified