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NCT00469586 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— iINHALE 7  

Official title:
Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00469586
Other study ID # NN1998-1787
Secondary ID 2006-004623-12
Status Terminated
Phase Phase 3
First received May 3, 2007
Last updated February 28, 2017
Start date April 26, 2007
Est. completion date April 24, 2008

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Terminated
Enrollment 174
Est. completion date April 24, 2008
Est. primary completion date April 24, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
• metformin
Tablets, 2000 mg/day.
• glimepiride
Tablets, 4 mg/day.
• inhaled human insulin
Treat-to-target dose titration scheme, post-prandial, inhalation.

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad de Mendoza
Argentina Novo Nordisk Investigational Site Mar del Plata
Austria Novo Nordisk Investigational Site Ebreichsdorf
Austria Novo Nordisk Investigational Site Kittsee
Austria Novo Nordisk Investigational Site Salzburg
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Belgium Novo Nordisk Investigational Site Arlon
Belgium Novo Nordisk Investigational Site Bonheiden
Belgium Novo Nordisk Investigational Site Borsbeek
Belgium Novo Nordisk Investigational Site Gent
Belgium Novo Nordisk Investigational Site Huy
Belgium Novo Nordisk Investigational Site Leuven
Bulgaria Novo Nordisk Investigational Site Sofia
Bulgaria Novo Nordisk Investigational Site Sofia
Canada Novo Nordisk Investigational Site Edmonton Alberta
Canada Novo Nordisk Investigational Site Halifax Nova Scotia
Canada Novo Nordisk Investigational Site Hamilton Ontario
Canada Novo Nordisk Investigational Site Laval Quebec
Canada Novo Nordisk Investigational Site Mississauga
Canada Novo Nordisk Investigational Site Oshawa
Canada Novo Nordisk Investigational Site Saskatoon
Canada Novo Nordisk Investigational Site Sherbrooke Quebec
Canada Novo Nordisk Investigational Site Smiths Falls Ontario
Canada Novo Nordisk Investigational Site Trois-Rivieres
Canada Novo Nordisk Investigational Site Winnipeg Manitoba
France Novo Nordisk Investigational Site Corbeil Essonnes
France Novo Nordisk Investigational Site Nantes
France Novo Nordisk Investigational Site Narbonne
France Novo Nordisk Investigational Site NEVERS cedex
France Novo Nordisk Investigational Site Paris
France Novo Nordisk Investigational Site Roubaix
India Novo Nordisk Investigational Site Bangalore
India Novo Nordisk Investigational Site Coimbatore
India Novo Nordisk Investigational Site Hyderabad
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Thriruvananthapuram
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Holon
Israel Novo Nordisk Investigational Site Jerusalem
Mexico Novo Nordisk Investigational Site Guadalajara
Mexico Novo Nordisk Investigational Site Mexico city
Mexico Novo Nordisk Investigational Site Mexico city
Mexico Novo Nordisk Investigational Site Mexico City México, D.F.
Mexico Novo Nordisk Investigational Site Monterrey Nuevo León
Poland Novo Nordisk Investigational Site Gdansk
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Mazowieckie
Poland Novo Nordisk Investigational Site Rawa Mazowiecka
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Zabrze
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Konya

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  France,  India,  Israel,  Mexico,  Poland,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c change from baseline After 18 weeks of treatment
Secondary Adverse events For the duration of the trial
Secondary Body weight after 18 weeks of treatment
Secondary Lung function after 18 weeks of treatment
Secondary Blood glucose after 18 weeks of treatment
Secondary Hypoglycaemia after 18 weeks of treatment
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