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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00665808
First received: April 22, 2008
Last updated: June 26, 2012
Last verified: June 2012

April 22, 2008
June 26, 2012
October 2007
December 2008   (final data collection date for primary outcome measure)
treatment satisfaction (DTSQs and DTSQc) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665808 on ClinicalTrials.gov Archive Site
  • diabetes-related quality of life (ADDQoL) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • general health-related quality of life (EQ-5D) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • metabolic control (HbA1c, fasting morning blood glucose) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • concomitant diabetes therapy (OADs) [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Adverse drug reactions, ADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Serious adverse drug reactions, SADR [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
  • Pregnancy [ Time Frame: over whole study duration, 24 weeks per patient ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
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

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
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®

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
    Other Name: Levemir®
  • Drug: isophane human insulin
    Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
  • A
    Intervention: Drug: insulin detemir
  • B
    Intervention: Drug: isophane human insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8125
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00665808
NN304-1951
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Martin Grundner Novo Nordisk Pharma GmbH
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP