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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779413
• Other study ID #: NN1250-4110
• Secondary ID: U1111-1176-2287
• Status: Completed
• Start date: June 2, 2016
• Est. completion date: June 24, 2019

Study information

• Verified date: April 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3303
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• insulin degludec
Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.

Locations

Country	Name	City	State
Korea, Republic of	Novo Nordisk Investigational Site	Bucheon
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	Novo Nordisk Investigational Site	Busan
Korea, Republic of	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	Novo Nordisk Investigational Site	Daegu
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Daejeon
Korea, Republic of	Novo Nordisk Investigational Site	Gangwon-do
Korea, Republic of	Novo Nordisk Investigational Site	Gangwon-do
Korea, Republic of	Novo Nordisk Investigational Site	Gangwon-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeongsangbuk-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeongsangbuk-do
Korea, Republic of	Novo Nordisk Investigational Site	Gyeongsangnam-do
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Incheon
Korea, Republic of	Novo Nordisk Investigational Site	Jeonju
Korea, Republic of	Novo Nordisk Investigational Site	Pyungchon-Dong 896, Dongan-Gu
Korea, Republic of	Novo Nordisk Investigational Site	Seongnam-si
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Suwon
Korea, Republic of	Novo Nordisk Investigational Site	Suwon-si, Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Ulsan
Korea, Republic of	Novo Nordisk Investigational Site	Ulsan
Korea, Republic of	Novo Nordisk Investigational Site	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk