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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Asthma Diabetes Diabetes Medicines Diabetes Type 1 Diabetes Type 2

Drug Information available for: Insulin Insulin beef

U.S. FDA Resources

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 78 Study Locations

Sponsors and Collaborators

Mannkind Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00332826 History of Changes
Other Study ID Numbers:	MKC-TI-105
Study First Received:	June 1, 2006
Last Updated:	October 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:

Inhaled insulin
Diabetes Type I and II with Asthma

Additional relevant MeSH terms:

Asthma
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012