Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

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

Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

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)

301

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

  • Austria
      • Ebreichsdorf, Austria, 2483
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
  • Finland
      • Joensuu, Finland, 80130
        • Novo Nordisk Investigational Site
      • Kirkkonummi, Finland, 02400
        • Novo Nordisk Investigational Site
      • Turku, Finland, FI-20520
        • Novo Nordisk Investigational Site
  • France
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • 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
      • Pessac, France, 33600
        • Novo Nordisk Investigational Site
      • Pointe à Pitre, France, 97159
        • Novo Nordisk Investigational Site
      • Roubaix, France, 59100
        • Novo Nordisk Investigational Site
      • Tours, France, 37044
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Novo Nordisk Investigational Site
      • Augsburg, Germany, 86150
        • Novo Nordisk Investigational Site
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13355
        • Novo Nordisk Investigational Site
      • Darmstadt, Germany, 64283
        • Novo Nordisk Investigational Site
      • Dormagen, Germany, 41539
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Flörsheim, Germany, 65439
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Fulda, Germany, 36037
        • Novo Nordisk Investigational Site
      • Genthin, Germany, 39307
        • Novo Nordisk Investigational Site
      • Hermaringen, Germany, 89568
        • Novo Nordisk Investigational Site
      • Kutenholz-Mulsum, Germany, 27449
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Pirna, Germany, 01796
        • Novo Nordisk Investigational Site
      • Schkeuditz, Germany, 04435
        • Novo Nordisk Investigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk Investigational Site
      • Wiesbaden, Germany, 65191
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Waterford, Ireland
        • Novo Nordisk Investigational Site
  • Netherlands
      • Delft, Netherlands, 2625 AD
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2597 AX
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2582 LJ
        • Novo Nordisk Investigational Site
      • Drachten, Netherlands, 9202 NN
        • Novo Nordisk Investigational Site
      • Rijswijk, Netherlands, 2281 AK
        • Novo Nordisk Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • Novo Nordisk Investigational Site
      • Vlodrop, Netherlands, 6063 DA
        • Novo Nordisk Investigational Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • Novo Nordisk Investigational Site
  • Spain
      • Alcira, Spain, 46600
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Gijón, Spain, 33206
        • Novo Nordisk Investigational Site
      • Majadahonda, Spain, 28222
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Novo Nordisk Investigational Site
      • Partida de Bacarot, Spain, 03114
        • Novo Nordisk Investigational Site
      • Pontevedra, Spain, 36071
        • Novo Nordisk Investigational Site
      • Reus, Spain, 43201
        • Novo Nordisk Investigational Site
      • San Juan, Spain, 03550
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
  • Switzerland
      • Interlaken-Unterseen, Switzerland, 3800
        • Novo Nordisk Investigational Site
      • Olten, Switzerland, 4600
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8032
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 1LD
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 2SR
        • Novo Nordisk Investigational Site
      • Belfast, United Kingdom, BT12 6BA
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
      • Trowbridge, United Kingdom, BA14 8QA
        • Novo Nordisk Investigational Site
      • Trowbridge, United Kingdom, BA14 9AR
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • Novo Nordisk Investigational Site
      • York, United Kingdom, YO3 7HE
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Treated with OAD(s) for more than or equal to 2 months
  • Body mass index of (BMI) less than or equal to 40.0 kg/m2
  • HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

  • Recurrent major hypoglycaemia
  • Current smoking or smoking within the last 6 months
  • Impaired hepatic or renal function
  • Cardiac disorders
  • Uncontrolled hypertension
  • 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: A
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Names:
  • NN1998
Drug: metformin
Tablets, 2000 mg/day.
Active Comparator: B
Drug: metformin
Tablets, 2000 mg/day.
Drug: rosiglitazone
Tablets, 4 mg once or twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment difference in HbA1c
Time Frame: After 26 weeks
After 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: For the duration of the trial
For the duration of the trial
Body weight
Time Frame: For the duration of the trial
For the duration of the trial
Lung function
Time Frame: For the duration of the trial
For the duration of the trial
Blood glucose
Time Frame: For the duration of the trial
For the duration of the trial
Hypoglycaemia
Time Frame: For the duration of the trial
For the duration of the trial

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)

October 30, 2006

Primary Completion (Actual)

March 5, 2008

Study Completion (Actual)

March 5, 2008

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 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

  • NN1998-1390
  • 2006-000796-15 (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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