Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma - Tabular View

Tracking Information
First Received Date ^ICMJE	June 1, 2006
Last Updated Date	October 12, 2009
Start Date ^ICMJE	June 2006
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2007)	The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Original Primary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Measurements of post bronchodilator FEV1 throughout the 12 month treatment period.
Change History	Complete list of historical versions of study NCT00332826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE (submitted: June 1, 2006)	Measurement of change in Asthma exacerbation frequency throughout the 12 month treatment period. Measurement of change in Asthma Control Questionnaire (ACQ) throughout the 12 month treatment period. Measurement of change in daily PEF as measured by the electronic peak flow meter throughout the 12 month treatment period.

Descriptive Information
Brief Title ^ICMJE	Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Official Title ^ICMJE	A Phase 3, 12-month Treatment, Multicenter, Randomized, Open-Label, Parallel Group Clinical Trial Comparing Prandial Subcutaneous Insulin With Prandial Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Brief Summary	The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Condition ^ICMJE	Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma
Intervention ^ICMJE	Drug: Technosphere Insulin
Study Arms / Comparison Groups
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	Terminated
Enrollment ^ICMJE	193
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents) Subjects must exhibit <30% variability in PEF measurements during the 2 week run in period. Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period Body mass index (BMI) < 40kg/m2 HbA1c >6.0% to <11.5% Exclusion Criteria: Severe complications of diabetes in the opinion of the investigator Seizure disorder Significant cardiovascular dysfunction and/or history within 3 months of screening Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure >110 mm HG at screening despite pharmacologic therapy. Clinical nephrotic syndrome or renal dysfunction or disease Total daily insulin requirement of >1.4 U/kg body weight Clinical diagnosis of Step 4 asthma Use of >6 puffs/day of fast acting bronchodilator Currently using an insulin delivery pump Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening Two or more severe hypoglycemic episodes within the past 6 months. Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening. Current use of systemic steroids Subjects who currently smoke tobacco or who have smoked within the past 6 months Urine cotinine test of > 100ng/ml Current drug or alcohol abuse Clinically significant abnormalities on screening laboratory evaluation Cancer within the past 5 years or any history of lung neoplasms History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes. Active infection or history of severe infection with 30 days of screening. Anemia History of anaphylaxis and/or angioneurotic edema Diagnosis of chronic obstructive pulmonary disease (COPE) Previous exposure to any inhaled insulin product
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Brazil, Canada, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00332826
Responsible Party
Study ID Numbers ^ICMJE	MKC-TI-105
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