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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00605020 |
This trial is conducted in Europe.
The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin aspart Device: biphasic insulin aspart |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus |
Estimated Enrollment: | 710 |
Study Start Date: | December 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Wien, Austria, A 1090 | |
Germany, EK Uni Tübingen | |
Tübingen, EK Uni Tübingen, Germany, 72072 | |
Switzerland | |
Lugano, Switzerland, 6900 |
Study Director: | Jens Larsen | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN304-1558 |
Study First Received: | January 17, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00605020 |
Health Authority: | Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic |
Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |