A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere®/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up

Phase 1

• Conditions: Diabetes mellitus type II; MedDRA version: 9.1 Level: PT Classification code 10012601 Term: Diabetes mellitus

• Registration Number: EUCTR2006-000305-35-GB
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 668

Inclusion Criteria

Key inclusion criteria include: non-smoking males and females >/= 18 and 7.0% and /= 70% predicted (NHANES III); DLco >/= 70% predicted (Miller) Total Lung Capacity >/= 80% predicted (ITS)
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

Key exclusion criteria include: subjects receiving concomitant sulphonylureas, meglitinides, alpha glucosidase inhibitors, pramlintide acetate (Symlin®), and/or any incretins (eg, exenatides, such as Byetta®) within the preceding 8 weeks; history of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >/= 3 times the upper limit of normal); history of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14),and/or any other clinically important pulmonary disease confirmed by documented history, pulmonary function testing, or radiologic findings; or evidence of severe complications of diabetes

Study & Design

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