Clinical trial NCT00348712: Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official title: Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment difference in HbA1c
timeFrame: After 26 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: For the duration of the trial
measure: Body weight
timeFrame: For the duration of the trial
measure: Lung function
timeFrame: For the duration of the trial
measure: Blood glucose
timeFrame: For the duration of the trial
measure: Hypoglycaemia
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Ebreichsdorf
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Joensuu
country: Finland
facility: Novo Nordisk Investigational Site
city: Kirkkonummi
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Corbeil Essonnes
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Mougins
country: France
facility: Novo Nordisk Investigational Site
city: Nanterre
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: Pessac
country: France
facility: Novo Nordisk Investigational Site
city: Pointe à Pitre
country: France
facility: Novo Nordisk Investigational Site
city: Roubaix
country: France
facility: Novo Nordisk Investigational Site
city: Tours
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Augsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Darmstadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Flörsheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Fulda
country: Germany
facility: Novo Nordisk Investigational Site
city: Genthin
country: Germany
facility: Novo Nordisk Investigational Site
city: Hermaringen
country: Germany
facility: Novo Nordisk Investigational Site
city: Kutenholz-Mulsum
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Pirna
country: Germany
facility: Novo Nordisk Investigational Site
city: Schkeuditz
country: Germany
facility: Novo Nordisk Investigational Site
city: Wangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wiesbaden
country: Germany
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Waterford
country: Ireland
facility: Novo Nordisk Investigational Site
city: Delft
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Drachten
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rijswijk
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Vlodrop
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zwijndrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Alcira
country: Spain
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Gijón
country: Spain
facility: Novo Nordisk Investigational Site
city: Majadahonda
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Partida de Bacarot
country: Spain
facility: Novo Nordisk Investigational Site
city: Pontevedra
country: Spain
facility: Novo Nordisk Investigational Site
city: Reus
country: Spain
facility: Novo Nordisk Investigational Site
city: San Juan
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Interlaken-Unterseen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Olten
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bradford-on-Avon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Salford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Trowbridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Trowbridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: York
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: