NCT02392117|CompletedFDA Drug

Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus

ReFLeCT

A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-4189U1111-1158-0248ENCEPP/SDPP/7880

Study Type

observational

Target

1,262

Locations

8 countries

Sites

Timeline

RegisteredMar 2015

StartedMar 2015

CompletionMar 2018

Brief Summary

This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,262

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach

8 countries

8 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 years study duration

First Submitted

Initial submission to the registry

March 12, 2015

Completed

4 days until next milestone

Study Start

First participant enrolled

March 16, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed

Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

March 12, 2015

Last Update Submit

September 30, 2019

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in the number of any hypoglycaemic episodes
End of 4 week baseline period, end of 12 month observation period

Secondary Outcomes (4)

Change from baseline in HbA1c (glycosylated haemoglobin)
0- 12 months
Change from baseline in FPG (Fasting Plasma Glucose)
0-12 months
Change from the baseline period in the number of severe hypoglycaemic episodes
0-12 months
Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))
0-12 months

Study Arms (1)

Insulin degludec

Drug: insulin degludec

Interventions

insulin degludecDRUG

Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.

Insulin degludec

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.

You may qualify if:

Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
Male or female patients at least 18 years of age at time of informed consent
Planned initiation with Tresiba®

You may not qualify if:

Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
Previous participation in this study (i.e. provision of informed consent)
Patients who have previously been treated with Tresiba®
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Contact the study team to confirm eligibility.