Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

NCT01890993 | Completed

• 3 other identifiers: NN2211-4077U1111-1142-2764ENCEPP/SDPP/8135
• Study Type: observational
• Target: 952
• Locations: 4 countries
• Sites: 4

Brief Summary

This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (glycosylated haemoglobin)

  Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)

Secondary Outcomes (2)

• Change in body weight

  Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)

• Change in systolic blood pressure

  Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)

Study Arms (2)

Liraglutide

Drug: liraglutide

DPP-4

Drug: liraglutide

Interventions

liraglutide DRUG

Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.

DPP-4; Liraglutide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (+/-2) months of available data will be included in this study. Only data derived from patients receiving either therapy in accordance with license indications will be included and analyzed.

You may qualify if:

• Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months

You may not qualify if:

• Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (4)

Unknown Facility

Paris La Défense Cedex, 92932, France

Location

Unknown Facility

Mainz, 55127, Germany

Location

Unknown Facility

Madrid, 28033, Spain

Location

Unknown Facility

Crawley, RH11 9RT, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide

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

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

GB (1); ES (1); FR (1); DE (1)