Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	March 28, 2006
Last Updated Date	February 28, 2008
Start Date ^†	June 2005
Current Primary Outcome Measures ^† (submitted: September 27, 2006)	To evaluate and compare changes in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^† (submitted: March 29, 2006)	Compare the incidence of a decrease in FEV1 of 15% or more Evaluate and compare changes in pulmonary function as measured by forced expiratory volume in 1 second (FEV1)
Change History	Complete list of historical versions of study NCT00308737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: February 28, 2008)	To evaluate and compare glycemic control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^† (submitted: March 29, 2006)	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) Evaluate the incidence of a decrease in FVC or TLC of 15% or more, or a decrease in DLco of more than 3 mLCO/min/mmHg Evaluate and compare HbA1c between the 2 diabetes treatment groups and to evaluate and compare the incidence and frequency of defined hypoglycemia between the 2 diabetes treatment groups Evaluate and compare changes in lung function between subjects with diabetes and subjects without abnormalities in glucose metabolism Compare changes in diabetes treatment groups as a function of baseline glycemic control.

Descriptive Information
Brief Title ^†	Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Official Title ^†	Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
Brief Summary	Pulmonary Safety in Diabetics with T/I
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Condition ^†	Diabetes, Type I Diabetes Type 2
Intervention ^†	Drug: Technosphere Insulin Drug: Usual Care Other: No Intervention
Study Arms / Comparison Groups	Experimental: Technosphere Insulin Other: Usual care No Intervention: Subjects without abnormalities in glucose control
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	2343
Completion Date	August 2008
Estimated Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: For All Subjects: Nonsmoking Body mass index <42 kg/m2 FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening, No abnormalities in screening pulmonary radiology For Subjects with diabetes mellitus: Type 1 or type 2 diabetes for at least 2 years HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 % For Subjects without abnormalities in glucose control: No history of diabetes Normal results from a formal glucose tolerance test Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease Significant renal, hepatic, or cardiac disease Women who are pregnant, lactating, or planning on becoming pregnant Subjects who have participated in studies of other investigational drugs within the previous 3 months Evidence of severe complications of diabetes
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States, Canada, Czech Republic, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00308737
Responsible Party	Anders Boss, MD, MFPM, Chief Medical Officer & Senior Vice President, MannKind Corporation
Secondary IDs ^††
Study Sponsor ^†	Mannkind Corporation
Collaborators ^††
Investigators ^†
Information Provided By	Mannkind Corporation
Verification Date	February 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.