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

NCT ID: NCT01484262

Last Updated: 2018-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-14

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liraglutide

liraglutide

Intervention Type DRUG

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

Any insulin

insulin

Intervention Type DRUG

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

Interventions

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liraglutide

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 30157532 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1123-5044

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3962

Identifier Type: -

Identifier Source: org_study_id

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