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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02392117
• Collaborator: (none)
• Enrollment: 1,262
• Locations: 8
• Actual Duration (Months): 36.1
• Patients Per Site: 157.8
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Drug: insulin degludec

Study Design

• Study Type: Observational
• Actual Enrollment: 1262 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Mar 16, 2015
• Actual Primary Completion Date: Mar 19, 2018
• Actual Study Completion Date: Mar 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Insulin degludec	Drug: insulin degludec; 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Change from baseline in HbA1c (glycosylated haemoglobin) [0- 12 months]

2. Change from baseline in FPG (Fasting Plasma Glucose) [0-12 months]

3. Change from the baseline period in the number of severe hypoglycaemic episodes [0-12 months]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study

• Planned initiation with Tresiba®

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Århus		Denmark	8200
2	Novo Nordisk Investigational Site	München		Germany	81925
3	Novo Nordisk Investigational Site	Padova		Italy	35122
4	Novo Nordisk Investigational Site	Utrecht		Netherlands	3508 GA
5	Novo Nordisk Investigational Site	Palma de Mallorca		Spain	07015
6	Novo Nordisk Investigational Site	Karlstad		Sweden	651 85
7	Novo Nordisk Investigational Site	Zürich		Switzerland	8091
8	Novo Nordisk Investigational Site	London		United Kingdom	SW10 9NH

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02392117
• Other Study ID Numbers: NN1250-4189; U1111-1158-0248; ENCEPP/SDPP/7880
• First Posted: Mar 18, 2015
• Last Update Posted: Oct 2, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Insulin

Study Results

No Results Posted as of Oct 2, 2019