Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes - Tabular View

Tracking Information
First Received Date ^ICMJE	March 27, 2006
Last Updated Date	October 1, 2009
Start Date ^ICMJE	February 2006
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 19, 2009)	Compare the mean change from baseline to Week 52 in HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 27, 2006)	Change in HbA1c
Change History	Complete list of historical versions of study NCT00308308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: March 27, 2006)	Evaluate the safety of T/ I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests. Compare the AUC postprandial venous plasma glucose values between treatment groups following a standardized liquid meal at selected times; Evaluate the proportion of subjects with HbA1c ≤ 7.0% and ≤ 8.0%. Evaluate changes in the SF-36 Quality of Life (QoL) instrument between treatment groups; Evaluate changes from the Insulin Treatment Questionnaire (ITQ) between treatment groups.

Descriptive Information
Brief Title ^ICMJE	Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Official Title ^ICMJE	A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up
Brief Summary	To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Diabetes, Type I
Intervention ^ICMJE	Drug: Technosphere Insulin Drug: Active comparator
Study Arms / Comparison Groups	Experimental: Technosphere Insulin Active Comparator: Comparator
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 ^ICMJE	Completed
Enrollment ^ICMJE	587
Completion Date	August 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of type 1 diabetes for at least 1 year Nonsmokers for prior 6 months BMI less than or equal to 35kg/m2 HbA1C> or = 7% and < or = 11% Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects FEV1> or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day Urine cotinine < or = 100 ng/mL Exclusion Criteria: History of Chronic obstructive pulmonary disease Asthma Any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings Evidence of severe complications of diabetes Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Canada, Chile, Mexico, Poland, Russian Federation, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00308308
Responsible Party	Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
Study ID Numbers ^ICMJE	MKC-TI-009
Study Sponsor ^ICMJE	Mannkind Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Mannkind Corporation
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP