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NCT Number: NCT00665808

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Other names: Levemir®

isophane human insulin

Drug

Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany

Primary outcomes

  1. treatment satisfaction (DTSQs and DTSQc)

    Time frame: over whole study duration, 24 weeks per patient

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2008
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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