In-market Utilisation of Liraglutide Used for Weight Management in Europe

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02967757
• Collaborator: (none)
• Enrollment: 316
• Locations: 19
• Actual Duration (Months): 29.1
• Patients Per Site: 16.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: liraglutide

Study Design

• Study Type: Observational
• Actual Enrollment: 316 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: In-market Utilisation of Liraglutide Used for Weight Management in Europe: a Retrospective Medical Record Review Study.
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: May 28, 2019
• Actual Study Completion Date: May 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg	Drug: liraglutide; Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients

Outcome Measures

Primary Outcome Measures

1. Number of patients with BMI above or equal to 30 kg/m^2 [Less than 6 months before date of first prescription]

2. Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity [Less than 6 months before date of first prescription]

   Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities

3. Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities [Less than 6 months before date of first prescription]

   Dysglycaemia (Type 2 Diabetes Mellitus [T2DM] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.

4. Number of patients with BMI below 27 kg/m^2 [Less than 6 months before date of first prescription]

5. Number of patients with BMI not measured [Within 6 months before date of the first prescription]

Secondary Outcome Measures

1. Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day [From date of first prescription until 24 months]

2. Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management [From date of first prescription until 24 months]

3. Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg [By 12 weeks after first prescription date]

   While adhering to the dose escalation according to label

4. Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg [From date of first prescription until 24 months]

   Number of patients

5. Number of patients with continued treatment with liraglutide 3.0 mg [From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months]

   Number of patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study

Exclusion Criteria:

-Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Bad Nauheim		Germany	61231
2	Novo Nordisk Investigational Site	Bünde		Germany	32257
3	Novo Nordisk Investigational Site	Essen		Germany	45147
4	Novo Nordisk Investigational Site	Hamburg		Germany	20097
5	Novo Nordisk Investigational Site	Kaiserslautern		Germany	67655
6	Novo Nordisk Investigational Site	Mainz		Germany	55124
7	Novo Nordisk Investigational Site	München		Germany	81477
8	Novo Nordisk Investigational Site	Münster		Germany	48143
9	Novo Nordisk Investigational Site	Ulm		Germany	89073
10	Novo Nordisk Investigational Site	Catania		Italy	95122
11	Novo Nordisk Investigational Site	Chieti		Italy	66100
12	Novo Nordisk Investigational Site	Cremona		Italy	26900
13	Novo Nordisk Investigational Site	Novara		Italy	28100
14	Novo Nordisk Investigational Site	Pisa		Italy	56126
15	Novo Nordisk Investigational Site	Potenza		Italy	85100
16	Novo Nordisk Investigational Site	Roma		Italy	00128
17	Novo Nordisk Investigational Site	Rome		Italy	00168
18	Novo Nordisk Investigational Site	Rome		Italy	161
19	Novo Nordisk Investigational Site	Siena		Italy	53100

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR,1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02967757
• Other Study ID Numbers: NN8022-4241; U1111-1185-3661; EUPAS16225
• First Posted: Nov 18, 2016
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Nutrition Disorders; Liraglutide

Study Results

No Results Posted as of Aug 5, 2019