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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Inhaled Insulin; Drug: Subcutaneous Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00137046

A2171022

Details and patient eligibility

About

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.

Full description

Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Enrollment: 582 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus

Exclusion criteria

• severe asthma or COPD
• smoking
• brittle diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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582 participants in 2 patient groups

Subcutaneous Insulin

Active Comparator group

Treatment:

Drug: Subcutaneous Insulin

Inhaled Insulin

Experimental group

Treatment:

Drug: Inhaled Insulin