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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01484262
First received: November 22, 2011
Last updated: January 8, 2014
Last verified: January 2014

November 22, 2011
January 8, 2014
November 2011
October 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01484262 on ClinicalTrials.gov Archive Site
  • Total cost of patient's diseases [ Time Frame: At the end of the observational period (52 weeks) ] [ Designated as safety issue: No ]
  • Total cost of patient education [ Time Frame: At the end of the observational period (52 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
  • 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.
  • Liraglutide
    Intervention: Drug: liraglutide
  • Any insulin
    Intervention: Drug: insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01484262
NN2211-3962, U1111-1123-5044
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Dr. Birgit Lüthgens Novo Nordisk Pharma GmbH
Novo Nordisk A/S
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP