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CompletedNCT01484262Updated Nov 1, 2018

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

An observational study in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,344
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,344 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,344 participants (actual)
Patient registry
No

Groups and cohorts

  • Liraglutide

    Drug: liraglutide

  • Any insulin

    Drug: insulin

Interventions

  • Drugliraglutide

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

  • Druginsulin

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

06

What researchers measure

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)

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Mainz, 55127, Germany
08

References and documents

Publications

  • Lundershausen R, Muller S, Hashim M, Kienhofer J, Kipper S, Wilke T. Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study. Exp Clin Endocrinol Diabetes. 2020 Mar;128(3):170-181. doi: 10.1055/a-0636-3961. Epub 2018 Aug 29. PubMed 30157532 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01484262
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Nov 14, 2011
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014
Last update
Nov 1, 2018

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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