Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT02321878
  4. Details
NCT02321878 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02321878
Other study ID # NN2211-4175
Secondary ID U1111-1157-6701
Status Completed
Phase N/A
First received December 17, 2014
Last updated August 31, 2017
Start date December 15, 2014
Est. completion date June 16, 2017

Study information
Verified date August 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1092
Est. completion date June 16, 2017
Est. primary completion date June 16, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions. No treatment given.

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Chichibu-city
Japan Novo Nordisk Investigational Site Koriyama-shi, Fukushima
Japan Novo Nordisk Investigational Site Oyama-shi, Tochigi
Japan Novo Nordisk Investigational Site Tagajo-shi
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of AEs (adverse events) Week 0-52
Secondary Number of adverse reactions (ARs) Week 0-52
Secondary Change in HbA1c (glycosylated haemoglobin) Week 0, week 52
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2

External Links