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Study 2 of 2219 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00795600 |
This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (both combined with insulin aspart in the main meals) in overweight and obese type 2 diabetics.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin NPH |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes Mellitus After 26 Weeks of Treatment With Insulin Detemir Versus Insulin NPH Both Combined With Insulin Aspart |
Estimated Enrollment: | 58 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: insulin detemir
Insulin detemir once daily plus insulin aspart at mealtime
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B: Active Comparator |
Drug: insulin NPH
Insulin NPH once daily plus insulin aspart at mealtime
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Public Access to Clinical Trials - Novo Nordisk | Please Contact NN via email | clinicaltrials@novonordisk.com |
Spain | |
Málaga, Spain, 29009 |
Study Director: | Fernando Fuentes, PhD | Novo Nordisk Pharma SA |
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN304-3614, EudraCT No: 2008-003739-19 |
Study First Received: | November 20, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00795600 |
Health Authority: | Spain: Spanish Agency of Medicines |
Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Overweight Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin, Isophane Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |