ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01226966
Date of registration:	20/10/2010
Prospective Registration:	No
Primary sponsor:	Novo Nordisk A/S
Public title:	Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes EVIDENCE
Scientific title:	Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes
Date of first enrolment:	September 2010
Target sample size:	3152
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01226966
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Global Clinical Registry (GCR, 1452), Medical Advisor
Address:
Telephone:
Email:
Affiliation:	Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients diagnosed with type 2 diabetes

- Patients having recently started (for less than one week) or starting liraglutide
(Victoza®) treatment

Exclusion Criteria:

- Hypersensitivity (allergy) to liraglutide or to any of the excipients

- Patient is participating in a clinical trial at the inclusion

- Type 1 diabetes

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: liraglutide

Primary Outcome(s)

Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0% [Time Frame: Month 24]

Secondary Outcome(s)

Change in fasting plasma glucose (FPG) at month 24 [Time Frame: Month 0, Month 24]

Change in fasting plasma glucose (FPG) at month 12 [Time Frame: Month 0, Month 12]

Change in Body Weight at Month 12 [Time Frame: Month 0, Month 12]

Change in fasting plasma glucose (FPG) at month 18 [Time Frame: Month 0, Month 18]

Change in Body Weight at Month 24 [Time Frame: Month 0, Month 24]

Change in Body Weight at Month 3 [Time Frame: Month 0, Month 3]

Change in fasting plasma glucose (FPG) at month 6 [Time Frame: Month 0, Month 6]

Change in HbA1c at month 18 [Time Frame: Month 0, Month 18]

Change in Body Weight at Month 6 [Time Frame: Month 0, Month 6]

Change in HbA1c at month 12 [Time Frame: Month 0, Month 12]

Change in fasting plasma glucose (FPG) at month 3 [Time Frame: Month 0, Month 3]

Change in HbA1c at month 24 [Time Frame: Month 0, Month 24]

Change in HbA1c at month 6 [Time Frame: Month 0, Month 6]

Change in Body Weight at Month 18 [Time Frame: Month 0, Month 18]

Change in HbA1c at month 3 [Time Frame: Month 0, Month 3]

Secondary ID(s)

U1111-1116-2722

NN2211-3815

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.