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OpenTrials
Completed

NCT Number: NCT00715351

Observational Study of Patients Using Levemir® or Insulatard® as Start Insulin for Treatment of Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control, weight change and hypoglycaemic effects in patients with type 2 diabetes with Levemir® compared to Insulatard® under normal clinical practice conditions.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Ljubljana, SI-1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes failing on oral blood glucose lowering therapy, and requiring insulin therapy.

Exclusion criteria

  • Type 1 diabetes
  • Previous use of insulin

Treatment and study plan

insulin detemir

Drug

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

insulin NPH

Drug

Physician decides which insulin should be prescribed, selection of subjects will be at the discretion of participating physician

Primary outcomes

  1. Body weight change

    Time frame: at 3 months and 6 months after baseline

Secondary outcomes

  1. Hypoglycemic events

    Time frame: at 3 months and 6 months after baseline

  2. Changes in glycaemic parameters

    Time frame: at 3 months and 6 months after baseline

  3. Safety parameters by collecting (serious) adverse events and the pregnancies.

    Time frame: at 3 months and 6 months after baseline

  4. Evaluation of general well-being by using the WHO-5 well-being questionnaire (Appendix I).

    Time frame: at 3 months and 6 months after baseline

  5. Treatment satisfaction of subjects treated with insulin Levemir or NPH insulin by using insulin satisfaction ('Tevredenheid met insuline behandeling': Appendix II)

    Time frame: at 3 months and 6 months after baseline

  6. Satisfaction of physicians who treat the subjects with insulin Levemir or NPH in-sulin by using a scale of 0-10 (Appendix III).

    Time frame: at 3 months and 6 months after baseline

  7. Changes in doses

    Time frame: at 3 months and 6 months after baseline

  8. HbA1c

    Time frame: at 3 months and 6 months after baseline

  9. Changes in daily blood glucose values

    Time frame: at 3 months and 6 months after baseline

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Glycaemic Control of Levemir® or Insulatard® in Patients With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2008
Registry last updated
Nov 25, 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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