Effect of Inhaled Pre-prandial Human Insulin on Blood Glucose Control in Type 2 Diabetes

• Status: Terminated
• Trial end date: 2008-03-11
• 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 or rosiglitazone treatment, both in combination with metformin and glimepiride.

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

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Glimepiride; Insulin; Insulin, Globin Zinc; Metformin; Rosiglitazone

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Currently treated with antidiabetes drugs (including Exenatide) for at least 2 months

• HbA1c between 7.5 and 11.0% (both inclusive) on antidiabetes combination therapy

• BMI less than or equal to 40 kg/m2

Exclusion Criteria:

• Current smoking or smoking within the last 6 months

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

• Proliferative retinopathy requiring acute treatment

• Clinically significant disease history including kidney or liver disease

• Heart disease which limits physical activity or results in discomfort with physical activity

• Pregnancy