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

NCT01484262 | Completed

• 2 other identifiers: NN2211-3962U1111-1123-5044
• Study Type: observational
• Target: 1,344
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)

  At the end of the observational period (52 weeks)

Secondary Outcomes (2)

• Total cost of patient's diseases

  At the end of the observational period (52 weeks)

• Total cost of patient education

  At the end of the observational period (52 weeks)

Study Arms (2)

Liraglutide

Drug: liraglutide

Any insulin

Drug: insulin

Interventions

liraglutide DRUG

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

Liraglutide

insulin 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.

Any insulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Location

Related Publications (1)

• 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.

  PMID: 30157532 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 2, 2011
• Study Start: November 14, 2011
• Primary Completion: October 31, 2014
• Study Completion: October 31, 2014
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

DE (1)