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Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

This study is ongoing, but not recruiting participants.
Study NCT00308308.   Last updated on February 28, 2008.   Information provided by Mannkind Corporation

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Descriptive Information Fields
Brief Title  Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Official Title  A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up
Brief Summary

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Compare the mean change in HbA1c from baseline. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Evaluate safety of treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Condition  Diabetes, Type I
Intervention  Drug: Technosphere Insulin
Drug: Human insulin aspart
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  570
Start Date  February 2006
Completion Date January 2008
Eligibility Criteria 

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for at least 1 year
  • Nonsmokers for prior 6 months
  • BMI less than or equal to 35kg/m2
  • HbA1C> or = 7% and < or = 11%
  • Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
  • FEV1> or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
  • Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
  • Urine cotinine < or = 100 ng/mL

Exclusion Criteria:

  • History of Chronic obstructive pulmonary disease
  • Asthma
  • Any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
  • Evidence of severe complications of diabetes
  • Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States,   Argentina,   Brazil,   Canada,   Chile,   Mexico,   Poland,   Russian Federation,   Spain,   United Kingdom
Administrative Information Fields
NCT ID  NCT00308308
Organization ID MKC-TI-009
Secondary IDs ††
Study Sponsor  Mannkind Corporation
Collaborators ††
Investigators 
Study Director:     Anders Boss     Mannkind Corporation    
Information Provided By Mannkind Corporation
Verification Date February 2008
First Received Date  March 27, 2006
Last Updated Date February 28, 2008

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




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