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Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00331604
Recruitment Status : Terminated (See termination reason in detailed description)
First Posted : May 31, 2006
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 24, 2006
First Posted Date  ICMJE May 31, 2006
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE August 31, 2006
Actual Primary Completion Date May 5, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2007)
Treatment difference in HbA1c [ Time Frame: After 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2006)
Treatment difference in HbA1c after 52 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Adverse events [ Time Frame: For the duration of the trial ]
  • Blood glucose [ Time Frame: After 52, 104 and 116 weeks of treatment ]
  • Body weight [ Time Frame: During treatment ]
  • Lung function [ Time Frame: After 52, 104 and 116 weeks of treatment ]
  • Hypoglycaemia [ Time Frame: From 12 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2006)
  • - Blood glucose
  • Hypoglycaemia
  • Body weight
  • Lung function
  • Adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes
Official Title  ICMJE Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
Brief Summary This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: inhaled human insulin
    Treat-to-target dose titration scheme, inhalation.
  • Drug: insulin detemir
    Injection s.c., 50% of daily dose.
    Other Names:
    • NN304
    • Levemir
  • Drug: insulin aspart
    Treat-to-target dose titration scheme, injection s.c.
  • Drug: insulin aspart
    Treat-to-target dose titration scheme, injection s.c. After 2 years.
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: inhaled human insulin
    • Drug: insulin detemir
  • Active Comparator: B
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
  • Active Comparator: C
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
    • Drug: insulin aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 30, 2008)
618
Original Enrollment  ICMJE
 (submitted: May 29, 2006)
546
Actual Study Completion Date  ICMJE May 5, 2008
Actual Primary Completion Date May 5, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with insulin
  • Body mass index of (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 11.0%

Exclusion Criteria:

  • Total daily insulin dosage less than or equal to 100 IU or U/day
  • Current smoking or smoking within the last 6 months
  • Cardiac problems
  • Uncontrolled hypertension
  • Current proliferative retinopathy or maculopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Singapore,   Spain,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00331604
Other Study ID Numbers  ICMJE NN1998-2161
2005-005378-58 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP