A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

April 20, 2020 updated by: Novo Nordisk A/S

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Tresiba® FlexTouch® (Insulin Degludec) to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in Korea

This study is conducted in Asia. The aim of the study is to evaluate safety and effectiveness in patients of all age groups excluding less than 12 month old infants with diabetes mellitus in routine clinical practice in Korea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14647
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 47392
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 49267
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 47227
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 49241
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Chungcheongnam-do, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 41199
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 361-711
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 302-718
        • Novo Nordisk Investigational Site
      • Gangwon-do, Korea, Republic of, 24253
        • Novo Nordisk Investigational Site
      • Gangwon-do, Korea, Republic of, 25440
        • Novo Nordisk Investigational Site
      • Gangwon-do, Korea, Republic of, 26426
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 14754
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 10475
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Gyeongsangbuk-do, Korea, Republic of, 39295
        • Novo Nordisk Investigational Site
      • Gyeongsangbuk-do, Korea, Republic of, 39371
        • Novo Nordisk Investigational Site
      • Gyeongsangnam-do, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 22332
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 405-220
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 21431
        • Novo Nordisk Investigational Site
      • Jeonju, Korea, Republic of, 54987
        • Novo Nordisk Investigational Site
      • Pyungchon-Dong 896, Dongan-Gu, Korea, Republic of, 431-796
        • Novo Nordisk Investigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06273
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03722
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06591
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 139-827
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06351
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 150-713
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 04551
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 04564
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 05278
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 07441
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 139-707
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 16499
        • Novo Nordisk Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • Novo Nordisk Investigational Site
      • Ulsan, Korea, Republic of, 682-060
        • Novo Nordisk Investigational Site
      • Ulsan, Korea, Republic of, 44455
        • Novo Nordisk Investigational Site
      • Wonju, Korea, Republic of, 220-701
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes mellitus requiring insulin therapy for whom it has been decided to start with Tresiba® FlexTouch® based on the clinical judgment by their treating physician will be enrolled during enrolment period

Description

Inclusion Criteria: - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - The decision to initiate treatment with commercially available Tresiba® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Male or Female, Age at least 12 months, at the time of signing informed consent with type 1 or type 2 diabetes mellitus and who is scheduled to start treatment with Tresiba® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing Information (KPI) Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Patients who are or have previously treated with Tresiba® FlexTouch® - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. However, paediatric patients can be enrolled when the patient's primary caregiver (e.g. parents) or legally acceptable representatives (LAR) are capable of giving study specific signed informed consent. Any chronic disorder or severe disease which in the opinion of the investigator might jeopardise patient's safety or compliance with the protocol - Female who is pregnant, breast-feeding or intends to become pregnant and is of child-baring potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin degludec
Drug: insulin degludec
Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Events (AE)
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Adverse Events (AE)
Time Frame: week 26± 2 weeks
week 26± 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin dose changes
Time Frame: Week 0, Week 26
Week 0, Week 26
Change in HbA1c
Time Frame: Week 0, week 13, week 26
Week 0, week 13, week 26
Percentage of patients achieving the target of HbA1c below 7.0%
Time Frame: At week 13
At week 13
Percentage of patients achieving the target of HbA1c below 7.0%
Time Frame: At week 26
At week 26
Change in fasting plasma glucose (FPG)
Time Frame: Week 0, week 13, week 26
Week 0, week 13, week 26
Changes in postprandial plasma glucose (PPG)
Time Frame: Week 0, week 13, week 26
Week 0, week 13, week 26
Number of Adverse reactions (AR)
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Adverse reactions (AR)
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Number of Serious AE
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Serious AE
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Number of Serious AR
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Serious AR
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Number of Unexpected AR
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Unexpected AR
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time Frame: Week 13± 2 weeks
Week 13± 2 weeks
Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
Time Frame: week 26± 2 weeks
week 26± 2 weeks
Weight gain
Time Frame: week 13 ± 2 weeks
week 13 ± 2 weeks
Weight gain
Time Frame: week 26± 2 weeks
week 26± 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

June 24, 2019

Study Completion (Actual)

June 24, 2019

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4110
  • U1111-1176-2287 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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