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)

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1890

Inclusion Criteria

Non smoking males or females aged 18 to 70 years and body mass index <42 kg/m2, an FEV1 greater than or equal to 70% of predicted, a DLco 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.

Subjects without abnormalities in glucose control: fasting plasma glucose less than 100 mg/dL (5.6mmol/L), 2 hour postprandial plasma glucose value less than 140 mg/dL (7.8mmol/L) and no value of plasma glucose between the fasting value and the 2 hour value greater than 200 mg/dL (11.1mmol/L).
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 or other significant pulmonary disease: significant renal, hepatic, or cardiac disease; women who are pregnant, lactating, or planning to become pregnant and subjects who have participated in studies of other investigational drugs within the previous 3 months. Subjects with diabetes mellitus: severe complications of diabetes (e.g. autonomic neuropathy, proliferative retinopathy/ blindness, renal failure, renal transplant and peripheral vascular disease).

Study & Design

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