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

Novo Nordisk A/S1 site in 1 country3,303 target enrollmentJune 2, 2016

ConditionsDiabetes

Interventionsinsulin degludec

Drugsinsulin degludec

Overview

Phase: Not Applicable
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 3303
Locations: 1
Primary Endpoint: Number of Adverse Events (AE)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2, 2016

End Date

June 24, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)

Arms & Interventions

Insulin degludec

Intervention: insulin degludec

Outcomes

Primary Outcomes

Number of Adverse Events (AE)

Time Frame: week 26± 2 weeks

Secondary Outcomes

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