Official Title: “Effect of Inhaled Pre-Prandial Human Insulin Plus Metformin & Glimepiride Versus Rosiglitazone Plus Metformin & Glimepiride on HbA1c in Subjects With Type 2 Diabetes”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

The decision to discontinue the development of AERx® is not due to any safety concerns.

An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone
  • Tablets, 4 mg once or twice daily.
• Drug: inhaled human insulin
  • Treat-to-target dose titration scheme, inhalation.
• Drug: metformin
  • Tablets, 2000 mg/day.
• Drug: glimepiride
  • Tablets, 8 mg/day.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• Change in HbA1c
  • Time Frame: After 26 weeks
    Safety Issue?: No

Secondary Measures

• Fasting plasma glucose
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Lipid profiles
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Hypoglycaemic episodes
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Glucose profiles
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Change in body weight
  • Time Frame: For the duration of the trial
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Yizhen Xu, M.D., Ph.D. Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00427154

Study ID Number: NN1998-1540

ClinicalTrials.gov Identifier: NCT00427154

Health Authority: United States: Food and Drug Administration

Clinical Trials at Novo Nordisk