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OpenTrials
Completed

NCT Number: NCT01484262

Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2

This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.

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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–70 year

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

  • Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
  • Patients willing and able to give signed consent on matching patient data with sick fund data
  • Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
  • Patient is a member of the involved sick fund (AOK Plus)

Exclusion criteria

  • Known or suspected contra-indication to the relevant study product according to current SPC
  • Previous participation in this study
  • History of type 1 diabetes mellitus
  • Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
  • Previous treatment with liraglutide
  • History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
  • Progressive fatal disease
  • Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
  • Patients without legal capacity

Treatment and study plan

liraglutide

Drug

Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.

Insulin

Drug

Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.

Primary outcomes

  1. Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)

    Time frame: At the end of the observational period (52 weeks)

Secondary outcomes

  1. Total cost of patient's diseases

    Time frame: At the end of the observational period (52 weeks)

  2. Total cost of patient education

    Time frame: At the end of the observational period (52 weeks)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2011
Registry last updated
Nov 1, 2018

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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