NCT02779413|Completed

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

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/S ClinicalTrials.gov

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2 other identifiers

NN1250-4110U1111-1176-2287

Study Type

observational

Target

3,303

Locations

1 country

Sites

Timeline

RegisteredMay 2016

StartedJun 2016

CompletionJun 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,303

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach

1 country

44 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

May 13, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed

13 days until next milestone

Study Start

First participant enrolled

June 2, 2016

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed

Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

May 13, 2016

Last Update Submit

April 20, 2020

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

Number of Adverse Events (AE)
Week 13± 2 weeks
Number of Adverse Events (AE)
week 26± 2 weeks

Secondary Outcomes (20)

Insulin dose changes
Week 0, Week 26
Change in HbA1c
Week 0, week 13, week 26
Percentage of patients achieving the target of HbA1c below 7.0%
At week 13
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
+15 more secondary outcomes

Study Arms (1)

Insulin degludec

Drug: insulin degludec

Interventions

insulin degludecDRUG

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

Insulin degludec

Eligibility Criteria

Age12 Months+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

Contact the study team to confirm eligibility.