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Clinical Trial Details

Trial ID: L3215
Source ID: NCT00469586
Associated Drug: Inhaled Human Insulin
Title: Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
Acronym: iINHALE 7
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: inhaled human insulin|DRUG: metformin|DRUG: glimepiride|DRUG: inhaled human insulin
Outcome Measures: Primary: HbA1c change from baseline, After 18 weeks of treatment | Secondary: Adverse events, For the duration of the trial|Body weight, after 18 weeks of treatment|Lung function, after 18 weeks of treatment|Blood glucose, after 18 weeks of treatment|Hypoglycaemia, after 18 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 174
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-04-26
Completion Date: 2008-04-24
Results First Posted:
Last Update Posted: 2017-03-01
Locations: Novo Nordisk Investigational Site, Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Ciudad de Mendoza, 5500, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7600FZN, Argentina|Novo Nordisk Investigational Site, Ebreichsdorf, 2483, Austria|Novo Nordisk Investigational Site, Kittsee, A 2421, Austria|Novo Nordisk Investigational Site, Salzburg, 5020, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Wien, A 1160, Austria|Novo Nordisk Investigational Site, Arlon, 6700, Belgium|Novo Nordisk Investigational Site, Bonheiden, 2820, Belgium|Novo Nordisk Investigational Site, Borsbeek, 2150, Belgium|Novo Nordisk Investigational Site, Gent, 9000, Belgium|Novo Nordisk Investigational Site, Huy, 4500, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8L 2X2, Canada|Novo Nordisk Investigational Site, Smiths Falls, Ontario, K7A 4W8, Canada|Novo Nordisk Investigational Site, Laval, Quebec, H7T 2P5, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1H 5N4, Canada|Novo Nordisk Investigational Site, Mississauga, L5M 2V8, Canada|Novo Nordisk Investigational Site, Oshawa, L1J 2K1, Canada|Novo Nordisk Investigational Site, Saskatoon, S7N 0W8, Canada|Novo Nordisk Investigational Site, Trois-Rivieres, G8T 7A1, Canada|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, Nantes, 44093, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, NEVERS cedex, 58033, France|Novo Nordisk Investigational Site, Paris, 75877, France|Novo Nordisk Investigational Site, Roubaix, 59100, France|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Bangalore, 560041, India|Novo Nordisk Investigational Site, Coimbatore, 641002, India|Novo Nordisk Investigational Site, Hyderabad, 600034, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Holon, 58100, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Mexico City, México, D.F., 14000, Mexico|Novo Nordisk Investigational Site, Monterrey, Nuevo León, 64460, Mexico|Novo Nordisk Investigational Site, Guadalajara, 44600, Mexico|Novo Nordisk Investigational Site, Mexico city, 03100, Mexico|Novo Nordisk Investigational Site, Mexico city, 11650, Mexico|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Lodz, 90-030, Poland|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Mazowieckie, 09-400, Poland|Novo Nordisk Investigational Site, Rawa Mazowiecka, 96-200, Poland|Novo Nordisk Investigational Site, Warszawa, 02-097, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Istanbul, 34093, Turkey|Novo Nordisk Investigational Site, Istanbul, 34371, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Konya, 42001, Turkey
URL: https://clinicaltrials.gov/show/NCT00469586