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: September 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: insulin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1361
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484262

Locations
Germany
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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01484262     History of Changes
Other Study ID Numbers: NN2211-3962, U1111-1123-5044
Study First Received: November 22, 2011
Last Updated: September 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2014