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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00424437
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-09
• Study Completion: 2000-09
• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-19
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-09
• Last Update Posted: 2007-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary outcome is 24 week change in baseline in HbA1c

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Laval, Quebec, Canada