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NCT00343980 Clinical Trial

Safety and Efficacy of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Safety and Efficacy of Inhaled Pre-prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00343980
Other study ID # NN1998-1682
Secondary ID
Status Terminated
Phase Phase 3
First received June 22, 2006
Last updated February 28, 2017
Start date October 10, 2006
Est. completion date March 10, 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 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)

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 363
Est. completion date March 10, 2008
Est. primary completion date March 10, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rosiglitazone
Tablets, 4 mg once or twice a day.
• inhaled human insulin
Treat-to-target dose titration scheme, pre-prandial, inhalation.
• glimepiride
Tablets, 4 mg/day.

Locations
Country Name City State
Australia Novo Nordisk Investigational Site Garran
Australia Novo Nordisk Investigational Site Kingswood
Australia Novo Nordisk Investigational Site St Leonards New South Wales
Australia Novo Nordisk Investigational Site Wollongong New South Wales
Croatia Novo Nordisk Investigational Site Osijek
Croatia Novo Nordisk Investigational Site Zagreb
India Novo Nordisk Investigational Site Bangalore
India Novo Nordisk Investigational Site Chennai
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Coimbatore
India Novo Nordisk Investigational Site Vellore Tamil Nadu
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Philippines Novo Nordisk Investigational Site Cebu City
Philippines Novo Nordisk Investigational Site Makati City
Philippines Novo Nordisk Investigational Site Manila
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Bursa
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul

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

Countries where clinical trial is conducted

Australia,  Croatia,  India,  Macedonia, The Former Yugoslav Republic of,  Philippines,  Russian Federation,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment difference in HbA1c After 26 weeks
Secondary Adverse events For the duration of the trial
Secondary Body weight during treatment
Secondary Lung function after 26 weeks of treatment
Secondary Blood glucose after 26 weeks of treatment
Secondary Hypoglycaemia from 12-26 weeks of treatment
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