Clinical trial NCT02779413: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 3303
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Adverse Events (AE)
timeFrame: Week 13± 2 weeks
measure: Number of Adverse Events (AE)
timeFrame: week 26± 2 weeks
Secondary outcomes:
measure: Insulin dose changes
timeFrame: Week 0, Week 26
measure: Change in HbA1c
timeFrame: Week 0, week 13, week 26
measure: Percentage of patients achieving the target of HbA1c below 7.0%
timeFrame: At week 13
measure: Percentage of patients achieving the target of HbA1c below 7.0%
timeFrame: At week 26
measure: Change in fasting plasma glucose (FPG)
timeFrame: Week 0, week 13, week 26
measure: Changes in postprandial plasma glucose (PPG)
timeFrame: Week 0, week 13, week 26
measure: Number of Adverse reactions (AR)
timeFrame: Week 13± 2 weeks
measure: Number of Adverse reactions (AR)
timeFrame: week 26± 2 weeks
measure: Number of Serious AE
timeFrame: Week 13± 2 weeks
measure: Number of Serious AE
timeFrame: week 26± 2 weeks
measure: Number of Serious AR
timeFrame: Week 13± 2 weeks
measure: Number of Serious AR
timeFrame: week 26± 2 weeks
measure: Number of Unexpected AR
timeFrame: Week 13± 2 weeks
measure: Number of Unexpected AR
timeFrame: week 26± 2 weeks
measure: Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
timeFrame: Week 13± 2 weeks
measure: Number of Severe hypoglycaemia (PG (plasma glucose) below 56 mg/dl)
timeFrame: week 26± 2 weeks
measure: Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
timeFrame: Week 13± 2 weeks
measure: Number of Blood glucose (BG) confirmed hypoglycaemia (PG below 56 mg/dl)
timeFrame: week 26± 2 weeks
measure: Weight gain
timeFrame: week 13 ± 2 weeks
measure: Weight gain
timeFrame: week 26± 2 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Chungcheongnam-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeongsangbuk-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Incheon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Jeonju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Pyungchon-Dong 896, Dongan-Gu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Wonju
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: