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Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00665808
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: isophane human insulin

Study Design

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
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. treatment satisfaction (DTSQs and DTSQc) [ Time Frame: over whole study duration, 24 weeks per patient ]

Secondary Outcome Measures :
  1. diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ]
  2. general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ]
  3. Body weight [ Time Frame: over whole study duration, 24 weeks per patient ]
  4. metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ]
  5. Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ]
  6. concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ]
  7. Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ]
  8. Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ]
  9. Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ]
  10. Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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®
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

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


Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00665808     History of Changes
Other Study ID Numbers: NN304-1951
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs