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Completed

NCT Number: NCT00793273

Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.

This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.

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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

Zurich, Oerlikon, CH-8050, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with type 2 diabetes mellitus
  • Insulin-naive or currently treated with another basal insulin
  • Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®

Exclusion criteria

  • Type 1 diabetes mellitus
  • Patients treated with short acting or with premix insulin
  • Women who are pregnant, breast feeding or have the intention to become pregnant
  • Known or suspected allergy to the study product or related product
  • Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)

Treatment and study plan

insulin detemir

Drug

Effectiveness and safety data collection in connection with the use of the drug Levemir® in daily clinical practice

Other names: Levemir®, NN304

Primary outcomes

  1. Change in HbA1c of treatment

    Time frame: after 12 to 16 weeks

  2. Change in FPG (fasting plasma glucose) of treatment

    Time frame: after 12 to 16 weeks

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: after 12 to 16 weeks

  2. Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation

    Time frame: after 12 to 16 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Evaluation of Glycaemic Control After Initiation of Levemir® in Patients With Type 2 Diabetes Mellitus and Time Period Between Diagnosis of Type 2 Diabetes Mellitus and Insulin Initiation.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 19, 2008
Registry last updated
Aug 15, 2014

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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