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

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma	Drug: Technosphere Insulin	Phase III

MedlinePlus related topics:

Asthma Diabetes Diabetes Type 1

ChemIDplus related topics:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment

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

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:

The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period

Estimated Enrollment:	193
Study Start Date:	June 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332826

Show 79 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

Study ID Numbers:	MKC-TI-105
First Received:	June 1, 2006
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00332826
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:

Inhaled insulin

Diabetes Type I and II with Asthma

Study placed in the following topic categories:

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus

Asthma

Endocrine System Diseases

Insulin

Lung Diseases, Obstructive

Hypersensitivity

Diabetes Mellitus, Type 1

Respiratory Tract Diseases

Lung Diseases

Diabetes Mellitus, Type 2

Hypersensitivity, Immediate

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypoglycemic Agents

Immune System Diseases

Bronchial Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Mannkind Corporation
Information provided by:	Mannkind Corporation
ClinicalTrials.gov Identifier:	NCT00332826