Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

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: NCT00424333
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : February 13, 2007
Information provided by:

January 17, 2007
January 19, 2007
February 13, 2007
May 1999
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Primary outcome is 24 week change in baseline in HbA1c.
Same as current
Complete list of historical versions of study NCT00424333 on Archive Site
  • The secondary endpoints include the following efficacy assessments:
  • Incidence of hypoglycemia
  • Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
  • Change from baseline in fasting lipid profile
  • Change from baseline in fasting plasma glucose level
  • Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
  • Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
  • Change from baseline in body weight
  • Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
  • Patient satisfaction and preference.
Same as current
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Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

To determine in subjects with Type 1 Diabetes Mellitus:

  1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.
  2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Drug: Inhaled human insulin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2000
Not Provided

Inclusion Criteria:

  • Type 1 Diabetes for more than 1 year
  • Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

  • Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
  • Subjects on insulin pump during 2 months prior to screening.
  • Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Study Director: Pfizer Call Center Pfizer
February 2007

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