Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
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ClinicalTrials.gov Identifier: NCT00665808 |
Recruitment Status :
Completed
First Posted : April 24, 2008
Last Update Posted : October 28, 2016
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Condition or disease | Intervention/treatment |
---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: insulin detemir Drug: isophane human insulin |
Study Type : | Observational |
Actual Enrollment : | 8125 participants |
Time Perspective: | 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 |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Group/Cohort | Intervention/treatment |
---|---|
A |
Drug: insulin detemir
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
Other Name: Levemir® |
B |
Drug: isophane human insulin
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany |
- treatment satisfaction (DTSQs and DTSQc) [ Time Frame: over whole study duration, 24 weeks per patient ]
- diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ]
- general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ]
- Body weight [ Time Frame: over whole study duration, 24 weeks per patient ]
- metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ]
- Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ]
- concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ]
- Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ]
- Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ]
- Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ]
- Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Written informed consent obtained from patient before first documentation of treatment in the observational study.
- 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
- No contraindication for use of Protaphane® or Levemir®
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665808
Germany | |
Novo Nordisk Investigational Site | |
Mainz, Germany, 55127 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00665808 |
Other Study ID Numbers: |
NN304-1951 |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | October 28, 2016 |
Last Verified: | October 2016 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin, Globin Zinc |
Insulin Detemir Isophane Insulin, Human Insulin, Isophane Isophane insulin, beef Hypoglycemic Agents Physiological Effects of Drugs |