Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 2 Diabetes

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Subcutaneous insulin; Drug: Inhaled Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00136916

A2171029

Details and patient eligibility

About

This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.

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 A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Enrollment: 635 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus

Exclusion criteria

• COPD
• Asthma
• Smoking Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

635 participants in 2 patient groups

Inhaled Insulin

Experimental group

Description:

Inhalable short-acting insulin

Treatment:

Drug: Inhaled Insulin

Subcutaneous insulin

Active Comparator group

Treatment:

Drug: Subcutaneous insulin