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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Burlingame, California, United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type 1 Diabetes for more than 1 year

- Stable insulin regimen of at least 2 injections per day

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00424437
Pfizer
Completed
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

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

To determine, in subjects with Type 1 Diabetes Mellitus:

  1. 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.
  2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Drug: Inhaled human insulin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
September 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)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00424437
217-106
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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