Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

February 28, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

618

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Campinas, Brazil, 13083-900
        • Novo Nordisk Investigational Site
      • Higienopolis, Brazil, 01244-030
        • Novo Nordisk Investigational Site
      • Porto Alegre, Brazil, 90035-170
        • Novo Nordisk Investigational Site
      • Sao Paulo, Brazil, 04022-001
        • Novo Nordisk Investigational Site
  • Denmark
      • Hillerød, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Hvidovre, Denmark, 2650
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • France
      • Brest, France, 29200
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67091
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Harzburg, Germany, 38667
        • Novo Nordisk Investigational Site
      • Bad Kreuznach, Germany, 55545
        • Novo Nordisk Investigational Site
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 21073
        • Novo Nordisk Investigational Site
      • Herrenberg, Germany, 71083
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Neumünster, Germany, 24534
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Schkeuditz, Germany, 04435
        • Novo Nordisk Investigational Site
      • Speyer, Germany, 67346
        • Novo Nordisk Investigational Site
      • St. Ingbert, Germany, 66386
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Warburg, Germany, 34414
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Holon, Israel, 58100
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Novo Nordisk Investigational Site
      • Catania, Italy, 95122
        • Novo Nordisk Investigational Site
      • Catanzaro, Italy, 88100
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Perugia, Italy, 06126
        • Novo Nordisk Investigational Site
      • Pescara, Italy, 65124
        • Novo Nordisk Investigational Site
      • Pisa, Italy, 56100
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00133
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00168
        • Novo Nordisk Investigational Site
      • San Giovanni Rotondo, Italy, 71013
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37126
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novo Nordisk Investigational Site
      • Singapore, Singapore, 159964
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Cáceres, Spain, 10004
        • Novo Nordisk Investigational Site
      • Elche, Spain, 3203
        • Novo Nordisk Investigational Site
      • Granada, Spain, 18012
        • Novo Nordisk Investigational Site
      • Lugo, Spain, 27004
        • Novo Nordisk Investigational Site
      • Mostoles - Madrid -, Spain, 28935
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41014
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47011
        • Novo Nordisk Investigational Site
      • Xátiva, Spain, 46800
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taichung City, Taiwan, 407
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 114
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 1LD
        • Novo Nordisk Investigational Site
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL6 8BQ
        • Novo Nordisk Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • Levemir
  • NN304
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.
Experimental: A
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • Levemir
  • NN304
Active Comparator: C
Drug: insulin detemir
Injection s.c., 50% of daily dose.
Other Names:
  • Levemir
  • NN304
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment difference in HbA1c
Time Frame: After 52 weeks
After 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: For the duration of the trial
For the duration of the trial
Blood glucose
Time Frame: After 52, 104 and 116 weeks of treatment
After 52, 104 and 116 weeks of treatment
Body weight
Time Frame: During treatment
During treatment
Lung function
Time Frame: After 52, 104 and 116 weeks of treatment
After 52, 104 and 116 weeks of treatment
Hypoglycaemia
Time Frame: From 12 weeks of treatment
From 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2006

Primary Completion (Actual)

May 5, 2008

Study Completion (Actual)

May 5, 2008

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 29, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1998-2161
  • 2005-005378-58 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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