Pulmonary Outcomes within a 2-year Period in Subjects with Diabetes Mellitus Treated with Technosphere®/Insulin or Antidiabetic Treatment and in Subjects without Abnormalities in Glucose Control - PRiiSM (PRandial Inhaled Insulin versus Standard Management)

• Conditions: Diabetes mellitus; MedDRA version: 8.1Level: PTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2005-001436-72-CZ
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-02
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1890

Inclusion Criteria

Non smoking males or females aged 18 to 80 years and body mass index <42 kg/m2, an FEV1 greater than or equal to 70% of predicted, a DLco greater than or equal to 70% and TLC greater than or equal to 80% of predicted at screening and no abnormalities in screening pulmonary radiology. Subjects with diabetes mellitus: type 1 or type 2 diabetes for at least 2 years and a HbA1c greater than or equal to 6.6% and less than or equal to 12.0%. Subjects without abnormalities in glucose control: no history of diabetes, normal results from a formal glucose tolerance test.

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

History of chronic obstructive pulmonary disease (COPD), asthma, other significant pulmonary disease or sleep apnea; significant renal, hepatic, or cardiac disease; women who are pregnant, lactating, or planning on becoming pregnant; and subjects who have participated in studies of other investigational drugs within the previous 3 months. Subjects with diabetes mellitus: no severe complications of diabetes (eg symptomatic autonomic neuropathy; disabling peripheral neuropathy; proliferative retinopathy, nephropathy with renal failure, renal transplant and/or dialysis; foot ulcers; nontraumatic amputations; and/or vascular claudication)

Study & Design

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