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

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ClinicalTrials.gov Identifier: NCT00424333
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : February 13, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Inhaled human insulin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 1999
Study Completion Date : October 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources




Primary Outcome Measures :
  1. Primary outcome is 24 week change in baseline in HbA1c.

Secondary Outcome Measures :
  1. The secondary endpoints include the following efficacy assessments:
  2. Incidence of hypoglycemia
  3. Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
  4. Change from baseline in fasting lipid profile
  5. Change from baseline in fasting plasma glucose level
  6. Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
  7. Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
  8. Change from baseline in body weight
  9. 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).
  10. Patient satisfaction and preference.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00424333


  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00424333     History of Changes
Other Study ID Numbers: 217-107
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: February 13, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs