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Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
This study has been completed.
Study NCT00308308   Information provided by Mannkind Corporation
First Received: March 27, 2006   Last Updated: October 1, 2009   History of Changes

March 27, 2006
October 1, 2009
February 2006
July 2008   (final data collection date for primary outcome measure)
Compare the mean change from baseline to Week 52 in HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in HbA1c
Complete list of historical versions of study NCT00308308 on ClinicalTrials.gov Archive Site
 
  • Evaluate the safety of T/ I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests.
  • Compare the AUC postprandial venous plasma glucose values between treatment groups following a standardized liquid meal at selected times;
  • Evaluate the proportion of subjects with HbA1c ≤ 7.0% and ≤ 8.0%.
  • Evaluate changes in the SF-36 Quality of Life (QoL) instrument between treatment groups;
  • Evaluate changes from the Insulin Treatment Questionnaire (ITQ) between treatment groups.
 
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
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

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

 
Phase III
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Diabetes, Type I
  • Drug: Technosphere Insulin
  • Drug: Active comparator
  • Experimental: Technosphere Insulin
  • Active Comparator: Comparator
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
587
August 2008
July 2008   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Chile,   Mexico,   Poland,   Russian Federation,   Spain,   United Kingdom
 
NCT00308308
Anders Boss, MD, MFPM, Chief Medical Officer, MannKind Corporation
MKC-TI-009
Mannkind Corporation
 
 
Mannkind Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP