Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novo Nordisk |
---|---|
Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00348712 |
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).
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Inhaled Pre-Prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes |
Enrollment: | 298 |
Study Start Date: | November 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Drug: metformin
Tablets, 2000 mg/day.
|
B: Active Comparator |
Drug: rosiglitazone
Tablets, 4 mg once or twice daily.
Drug: metformin
Tablets, 2000 mg/day.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Vienna, Austria | |
Finland | |
Turku, Finland | |
France | |
Paris, France | |
Germany | |
Flörsheim, Germany | |
Ireland | |
Dublin, Ireland | |
Netherlands | |
Den Haag, Netherlands | |
Spain | |
San Juan de Alicante (Alicante), Spain | |
Switzerland | |
Zürich, Switzerland | |
United Kingdom | |
Swansea, United Kingdom |
Study Director: | Gitte S. Fuchs, BSc | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN1998-1390, EudraCT No: 2006-000796-15 |
Study First Received: | July 5, 2006 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00348712 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Finland: National Agency for Medicines; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; Ireland: Irish Medicines Board; Netherlands: The Central Committee on Research Involving Human Subjects (CCM; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Rosiglitazone Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |