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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00658099 |
This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
Condition | Intervention |
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Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin NPH |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus |
Enrollment: | 699 |
Study Start Date: | November 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A |
Drug: insulin detemir
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
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B |
Drug: insulin NPH
Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation
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Ages Eligible for Study: | 6 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Type 2 diabetes patiens failing on oral anti-diabetic agents
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN304-1976 |
Study First Received: | April 8, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00658099 History of Changes |
Health Authority: | Romania: National Medicines Agency |
Body Weight Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin, Isophane Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |