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Sponsored by: |
Novo Nordisk |
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Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00665808 |
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
Condition | Intervention |
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Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: isophane human insulin |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-Related and General Health-Related Quality of Life, as Well as Diabetes-Control |
Estimated Enrollment: | 12000 |
Study Start Date: | October 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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A |
Drug: insulin detemir
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
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B |
Drug: isophane human insulin
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients willing and able to give signed informed consent; Patients with Type 2 diabetes mellitus; Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control; Patients with no regular use of short acting insulin (occasional use for correction is allowed); Patients with no contraindication for use of Protaphane® or Levemir®
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN304-1951 |
Study First Received: | April 22, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00665808 History of Changes |
Health Authority: | Germany: BfArM |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Quality of Life |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |