Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Verified by: Novo Nordisk, February 2011
First Received: May 3, 2007 | Last Updated: February 22, 2011 | Phase: Phase 3 | Start Date: April 2007
Overall Status: Terminated | Estimated Enrollment: 174
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This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)...

Brief Summary

Official Title: “Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes”

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Detailed Clinical Trial Description

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: inhaled human insulin
    • Treat-to-target dose titration scheme, pre-prandial, inhalation.
  • Drug: metformin
    • Tablets, 2000 mg/day.
  • Drug: glimepiride
    • Tablets, 4 mg/day.
  • Drug: inhaled human insulin
    • Treat-to-target dose titration scheme, post-prandial, inhalation.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
  • Experimental: B
  • Active Comparator: C

Outcome Measures for this Clinical Trial

Primary Measures

  • HbA1c change from baseline
    • Time Frame: After 18 weeks of treatment
      Safety Issue?: No

Secondary Measures

  • Adverse events
    • Time Frame: For the duration of the trial
      Safety Issue?: No
  • Body weight
    • Time Frame: after 18 weeks of treatment
      Safety Issue?: No
  • Lung function
    • Time Frame: after 18 weeks of treatment
      Safety Issue?: No
  • Blood glucose
    • Time Frame: after 18 weeks of treatment
      Safety Issue?: No
  • Hypoglycaemia
    • Time Frame: after 18 weeks of treatment
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Type 2 diabetes
  • Treated with OADs for more than or equal to 3 months
  • HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

  • Recurrent major hypoglycaemia
  • Current smoking or smoking within the last 6 months
  • Impaired hepatic or renal function
  • Cardiac problems
  • Uncontrolled hypertension
  • Proliferative retinopathy or maculopathy

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

Clinical Trial Investigator Information

Lead Investigator: Novo Nordisk Industry

Overall Clinical Trial Officials and Contacts

Dorthe Lyngsoe Vuylsteke Study Director Novo Nordisk  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469586

Study ID Number: NN1998-1787

ClinicalTrials.gov Identifier: NCT00469586

Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Clinical Trials at Novo Nordisk

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