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

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Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

This study has been terminated.

Study NCT00332826. Last updated on March 21, 2008. Information provided by Mannkind Corporation

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

Descriptive Information Fields
Brief Title ^†	Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Primary Outcome Measure ^†	The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period
Secondary Outcome Measure ^†
Condition ^†	Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma
Intervention ^†	Drug: Technosphere Insulin
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Terminated
Enrollment ^†	193
Start Date ^†	June 2006
Completion Date	December 2007
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States, Argentina, Brazil, Canada, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine, United Kingdom

Administrative Information Fields
NCT ID ^†	NCT00332826
Organization ID	MKC-TI-105
Secondary IDs ^††
Study Sponsor ^†	Mannkind Corporation
Collaborators ^††
Investigators ^†
Information Provided By	Mannkind Corporation
Verification Date	March 2008
First Received Date ^†	June 1, 2006
Last Updated Date	March 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.