EUCTR2006-000305-35-GBActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- MannKind Corporation
- Enrollment
- 668
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
Investigators
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