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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01484262
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: insulin

Study Design

Study Type : Observational
Actual Enrollment : 1344 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
Study Start Date : November 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Liraglutide Drug: liraglutide
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
Any insulin Drug: insulin
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics (OADs), who need treatment intensification with insulin or liraglutide due to inadequate blood glucose control.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484262


Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01484262     History of Changes
Other Study ID Numbers: NN2211-3962
U1111-1123-5044 ( Other Identifier: WHO )
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists