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Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes

NCT00137046 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2010-02-18

Study results available
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Summary

This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).

This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Subcutaneous Insulin

Subcutaneous insulin with dose adjusted according to premeal blood glucose

DRUG

Inhaled Insulin

Inhaled insulin with dose adjusted according to premeal blood glucose

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00137046 on ClinicalTrials.gov