Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novo Nordisk |
---|---|
Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00537303 |
This trial is conducted in Europe, Africa and the USA. The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment, in type 2 diabetes
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin aspart |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Efficacy and Safety of Step-Wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes |
Enrollment: | 345 |
Study Start Date: | October 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: insulin detemir
Treat-to-target dose titration scheme, injection s.c.
Drug: insulin aspart
Administered 1 - 3 times daily, at largest prancial increment, injection s.c.
|
B: Active Comparator |
Drug: insulin detemir
Treat-to-target dose titration scheme, injection s.c.
Drug: insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Berit Gorsoe Kjeldsen, MSc | Novo Nordisk |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN304-1833, EudraCT No: 2007-000123-18 |
Study First Received: | September 28, 2007 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00537303 History of Changes |
Health Authority: | Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council; Spain: Spanish Agency for Medicines; Sweden: Medical Products Agency; Serbia: Medicines and Medical Devices Agency of Serbia; United Kingdom: Medicines and Healthcare Products Regulatory; United States: Food and Drug Administration; Norway: Norwegian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Denmark: Danish Medicines Agency |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Insulin, Asp(B28)- |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |