Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.
| Status | Terminated |
| Enrollment | 618 |
| Est. completion date | May 5, 2008 |
| Est. primary completion date | May 5, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Currently treated with insulin - Body mass index of (BMI) less than or equal to 40.0 kg/m2 - HbA1c less than or equal to 11.0% Exclusion Criteria: - Total daily insulin dosage less than or equal to 100 IU or U/day - Current smoking or smoking within the last 6 months - Cardiac problems - Uncontrolled hypertension - Current proliferative retinopathy or maculopathy |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Novo Nordisk Investigational Site | Campinas | |
| Brazil | Novo Nordisk Investigational Site | Higienopolis | |
| Brazil | Novo Nordisk Investigational Site | Porto Alegre | |
| Brazil | Novo Nordisk Investigational Site | Sao Paulo | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Hillerød | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | GRENOBLE cedex | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Germany | Novo Nordisk Investigational Site | Bad Harzburg | |
| Germany | Novo Nordisk Investigational Site | Bad Kreuznach | |
| Germany | Novo Nordisk Investigational Site | Bad Lauterberg | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Friedrichsthal | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Herrenberg | |
| Germany | Novo Nordisk Investigational Site | Hohenmölsen | |
| Germany | Novo Nordisk Investigational Site | Neumünster | |
| Germany | Novo Nordisk Investigational Site | Neuwied | |
| Germany | Novo Nordisk Investigational Site | Schkeuditz | |
| Germany | Novo Nordisk Investigational Site | Speyer | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Warburg | |
| Hong Kong | Novo Nordisk Investigational Site | Shatin, New Territories | |
| Israel | Novo Nordisk Investigational Site | Beer Sheva | |
| Israel | Novo Nordisk Investigational Site | Holon | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Italy | Novo Nordisk Investigational Site | Bari | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Catanzaro | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Perugia | |
| Italy | Novo Nordisk Investigational Site | Pescara | |
| Italy | Novo Nordisk Investigational Site | Pisa | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | San Giovanni Rotondo | |
| Italy | Novo Nordisk Investigational Site | Verona | |
| Singapore | Novo Nordisk Investigational Site | Singapore | |
| Singapore | Novo Nordisk Investigational Site | Singapore | |
| Spain | Novo Nordisk Investigational Site | Almería | |
| Spain | Novo Nordisk Investigational Site | Cáceres | |
| Spain | Novo Nordisk Investigational Site | Elche | |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Lugo | |
| Spain | Novo Nordisk Investigational Site | Mostoles - Madrid - | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Spain | Novo Nordisk Investigational Site | Valladolid | |
| Spain | Novo Nordisk Investigational Site | Xátiva | |
| Taiwan | Novo Nordisk Investigational Site | Taichung City | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| United Kingdom | Novo Nordisk Investigational Site | Aberdeen | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cosham | |
| United Kingdom | Novo Nordisk Investigational Site | Edgbaston, Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Edinburgh | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Wirral, Merseyside |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Brazil, Denmark, France, Germany, Hong Kong, Israel, Italy, Singapore, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment difference in HbA1c | After 52 weeks | ||
| Secondary | Adverse events | For the duration of the trial | ||
| Secondary | Blood glucose | After 52, 104 and 116 weeks of treatment | ||
| Secondary | Body weight | During treatment | ||
| Secondary | Lung function | After 52, 104 and 116 weeks of treatment | ||
| Secondary | Hypoglycaemia | From 12 weeks of treatment |
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