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Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)

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ClinicalTrials.gov Identifier: NCT02321878
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide

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Study Type : Observational
Actual Enrollment : 1092 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)
Actual Study Start Date : December 15, 2014
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Group/Cohort Intervention/treatment
Liraglutide Drug: liraglutide

Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.

No treatment given.





Primary Outcome Measures :
  1. Number of AEs (adverse events) [ Time Frame: Week 0-52 ]

Secondary Outcome Measures :
  1. Number of adverse reactions (ARs) [ Time Frame: Week 0-52 ]
  2. Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients with T2DM who the physician has decided to start on treatment with Victoza® in combination with insulin or oral anti-diabetes drug (OAD) other than SU (Sulfonylurea) will be eligible for this study.
Criteria

Inclusion Criteria:

  • Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
  • Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea)
  • Male or female, no age limitation

Exclusion Criteria:

  • Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321878


Locations
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Japan
Novo Nordisk Investigational Site
Chichibu-city, Japan, 368-0004
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, Japan, 963 8851
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, Japan, 323 0022
Novo Nordisk Investigational Site
Tagajo-shi, Japan, 985 0852
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02321878     History of Changes
Other Study ID Numbers: NN2211-4175
U1111-1157-6701 ( Other Identifier: WHO )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists