Clinical trial NCT00343980: Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes
Official title: Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride 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: 2006-06-23
Enrollment: 363
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 Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride 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 (BMI) less than or equal to 40.0 kg/m2
* HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
* HbA1c greater than or equal to 7.5 % 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 problems
* 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: during treatment
measure: Lung function
timeFrame: after 26 weeks of treatment
measure: Blood glucose
timeFrame: after 26 weeks of treatment
measure: Hypoglycaemia
timeFrame: from 12-26 weeks of treatment
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Kingswood
country: Australia
facility: Novo Nordisk Investigational Site
city: Osijek
country: Croatia
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Vellore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
city: Cebu City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Makati City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Manila
country: Philippines
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Bornova-IZMIR
country: Turkey
facility: Novo Nordisk Investigational Site
city: Bursa
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: