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Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

This study has been terminated.
(Non-safety related business decision to combine special population protocols)
Sponsor:
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00332826
First received: June 1, 2006
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  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 3

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:

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

Enrollment: 3
Study Start Date: June 2006
Study Completion Date: October 2007
Primary Completion Date: October 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: May 3, 2012
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 May 21, 2013