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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424437
First received: January 17, 2007
Last updated: February 9, 2007
Last verified: February 2007
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Inhaled human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 37 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014