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Trial · Observational

CompletedPhase not statedRegistry data

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

NCTNCT01484262 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3962Other idU1111-1123-5044
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
1,344 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
1 country

Germany

Start
14 Nov 2011
Primary completion
31 Oct 2014
Completion
31 Oct 2014
First posted
2 Dec 2011 (estimated)
Last update posted
1 Nov 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph –

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

    NCT01484262

    14 Nov 2011 to 31 Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • insulinDrug

Arms2

  • Other

    Liraglutide

  • Other

    Any insulin

Primary outcomes1

Outcomes the sponsor listed as primary.

  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(2)

  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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2020

9 results

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.

Lundershausen et al. 2020Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Associationcited by 5

PMID 30157532DOI 10.1055/a-0636-3961PUB-30157532

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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