COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332826
Recruitment Status : Terminated (Non-safety related business decision to combine special population protocols)
First Posted : June 2, 2006
Last Update Posted : May 4, 2012
Information provided by:
Mannkind Corporation

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Asthma Drug: Technosphere Insulin Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332826

Show Show 78 study locations
Sponsors and Collaborators
Mannkind Corporation

Layout table for additonal information Identifier: NCT00332826    
Other Study ID Numbers: MKC-TI-105
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Mannkind Corporation:
Inhaled insulin
Diabetes Type I and II with Asthma
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Autoimmune Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs