Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

• Status: Terminated
• Trial end date: 2008-03-18
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Pioglitazone

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Current treatment with oral antidiabetes drugs (OADs) for at least 2 months

• HbA1c between 7.0-11.0% if on OAD monotherapy

• HbA1c between 7.0-10.0% if on OAD combination therapy

• BMI less than or equal to 40 kg/m2

Exclusion Criteria:

• Current regular smoking or regular smoking within the last 6 months

• Current acute or chronic pulmonary disease (except for asthma)

• Proliferative retinopathy requiring treatment

• Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity

• Pregnancy