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

Last updated: February 28, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Terminated

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetic Vitreous Hemorrhage

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT00469586
NN1998-1787
2006-004623-12
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 174
Study Start date:
April 26, 2007
Estimated Completion Date:
April 24, 2008

Study 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.

Connect with a study center

  • Novo Nordisk Investigational Site

    Buenos Aires, C1425AGC
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad de Mendoza, 5500
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Mar del Plata, B7600FZN
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ebreichsdorf, 2483
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Kittsee, A 2421
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Salzburg, 5020
    Austria

    Site Not Available

  • empty

    Vienna,
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, A 1160
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlon, 6700
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Bonheiden, 2820
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Borsbeek, 2150
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Huy, 4500
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Novo Nordisk Investigational Site

    Edmonton, Alberta T5J 3N4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Smiths Falls, Ontario K7A 4W8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Laval, Quebec H7T 2P5
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Mississauga, L5M 2V8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Oshawa, L1J 2K1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Saskatoon, S7N 0W8
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Trois-Rivieres, G8T 7A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Corbeil Essonnes, 91106
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    NEVERS cedex, 58033
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Nantes, 44093
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Narbonne, 11108
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Paris, 75877
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Roubaix, 59100
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh 452010
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Bangalore, 560041
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Coimbatore, 641002
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Hyderabad, 600034
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Thriruvananthapuram, 695 032
    India

    Site Not Available

  • Novo Nordisk Investigational Site

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Holon, 58100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Mexico City, México, D.F. 14000
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Guadalajara, 44600
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Mexico city, 11650
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdansk, 80-858
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, 90-030
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, 20-044
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Mazowieckie, 09-400
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Rawa Mazowiecka, 96-200
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Warszawa, 02-097
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zabrze, 41-800
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Istanbul, 34718
    Turkey

    Site Not Available

  • Novo Nordisk Investigational Site

    Konya, 42001
    Turkey

    Site Not Available

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