Diabetes mellitus MedDRA version: 8.1 Level: PT Classification code 10012601 Term: Diabetes mellitus
Conditions
Sponsors
MannKind Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non smoking males or females aged 18 to 70 years and body mass index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: 1. To evaluate and compare changes in pulmonary function as measured by forced expiratory volume in one second (FEV1) 2. To compare the incidence of a decrease in FEV1 of 15% or more. (This threshold is chosen to exceed the measurement variability originating from technical and biological factors). ; Secondary Objective: The secondary objectives are: 1. To evaluate and compare the change in forced vital capacity (FVC), total lung capacity (TLC) and single –breath carbon monoxide diffusing capacity of the lung (DLco). 2. To evaluate the incidence of a decline in FVC or TLC of 15% or more, or a decrease in DLco of more than 3 mL CO/min/mm Hg. 3. To evaluate and compare glycemic control, expressed as the percent of glycosylated hemoglobin A1c (HbA1c) between the 2 diabetes treatment groups and to evaluate and compare the incidence and frequency of defined hypoglycaemia between the 2 diabetes groups. 4. To evaluate and compare changes in lung function between subjects with diabetes and subjects without abnormalities in glucose metabolism. 5. To compare changes in diabetes treatment groups as a function of baseline glycemic control. Other objectives will be to identify nontreatment related factors that are linked to decreases in pulmonary function. ;Primary end point(s): 1. Mean changes in FEV1 from baseline and decreases from baseline >15%. | — |
Countries
Czech Republic, Spain, United Kingdom
Outcome results
None listed