Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus. - Full Text View

Purpose

To determine, in subjects with Type 1 Diabetes Mellitus:

Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Inhaled human insulin	Phase III

MedlinePlus related topics:

Diabetes Diabetes Type 1

ChemIDplus related topics:

Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Further study details as provided by Pfizer:

Primary Outcome Measures:

Secondary Outcome Measures:

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.

Estimated Enrollment:	320
Study Start Date:	September 1999
Estimated Study Completion Date:	September 2000

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424437

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	217-106
First Received:	January 17, 2007
Last Updated:	February 9, 2007
ClinicalTrials.gov Identifier:	NCT00424437
Health Authority:	United States: Food and Drug Administration