Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes (iINHALE 7)

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

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 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)

174

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

  • Argentina
      • Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Ciudad de Mendoza, Argentina, 5500
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7600FZN
        • Novo Nordisk Investigational Site
  • Austria
      • Ebreichsdorf, Austria, 2483
        • Novo Nordisk Investigational Site
      • Kittsee, Austria, A 2421
        • Novo Nordisk Investigational Site
      • Salzburg, Austria, 5020
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1130
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1160
        • Novo Nordisk Investigational Site
  • Belgium
      • Arlon, Belgium, 6700
        • Novo Nordisk Investigational Site
      • Bonheiden, Belgium, 2820
        • Novo Nordisk Investigational Site
      • Borsbeek, Belgium, 2150
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Huy, Belgium, 4500
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1606
        • Novo Nordisk Investigational Site
  • Canada
      • Mississauga, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Oshawa, Canada, L1J 2K1
        • Novo Nordisk Investigational Site
      • Saskatoon, Canada, S7N 0W8
        • Novo Nordisk Investigational Site
      • Trois-Rivieres, Canada, G8T 7A1
        • Novo Nordisk Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novo Nordisk Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Novo Nordisk Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk Investigational Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Novo Nordisk Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Novo Nordisk Investigational Site
  • France
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Nantes, France, 44093
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Paris, France, 75877
        • Novo Nordisk Investigational Site
      • Roubaix, France, 59100
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560041
        • Novo Nordisk Investigational Site
      • Coimbatore, India, 641002
        • Novo Nordisk Investigational Site
      • Hyderabad, India, 600034
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • 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
  • Mexico
      • Guadalajara, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Mexico city, Mexico, 03100
        • Novo Nordisk Investigational Site
      • Mexico city, Mexico, 11650
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Mexico City, México, D.F., Mexico, 14000
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-030
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-044
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Mazowieckie, Poland, 09-400
        • Novo Nordisk Investigational Site
      • Rawa Mazowiecka, Poland, 96-200
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-097
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Turkey
      • Istanbul, Turkey, 34718
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34371
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34093
        • Novo Nordisk Investigational Site
      • Konya, Turkey, 42001
        • 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 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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Other Names:
  • NN1998
Drug: inhaled human insulin
Treat-to-target dose titration scheme, post-prandial, inhalation.
Other Names:
  • NN1998
EXPERIMENTAL: A
Drug: inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
Other Names:
  • NN1998
Drug: inhaled human insulin
Treat-to-target dose titration scheme, post-prandial, inhalation.
Other Names:
  • NN1998
ACTIVE_COMPARATOR: C
Drug: metformin
Tablets, 2000 mg/day.
Drug: glimepiride
Tablets, 4 mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c change from baseline
Time Frame: After 18 weeks of treatment
After 18 weeks of treatment

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: after 18 weeks of treatment
after 18 weeks of treatment
Lung function
Time Frame: after 18 weeks of treatment
after 18 weeks of treatment
Blood glucose
Time Frame: after 18 weeks of treatment
after 18 weeks of treatment
Hypoglycaemia
Time Frame: after 18 weeks of treatment
after 18 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)

April 26, 2007

Primary Completion (ACTUAL)

April 24, 2008

Study Completion (ACTUAL)

April 24, 2008

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (ESTIMATE)

May 4, 2007

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

  • NN1998-1787
  • 2006-004623-12 (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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