NCT03745157|Completed

RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan

RESILIENT

A Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN5401-4441U1111-1208-5143

Study Type

observational

Target

246

Locations

1 country

Sites

Timeline

RegisteredNov 2018

StartedNov 2018

CompletionOct 2019

Brief Summary

The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.

Trial Health

On Track

Trial Health Score

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

Enrollment

246

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach

1 country

29 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

11 months study duration

First Submitted

Initial submission to the registry

November 14, 2018

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed

2 days until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed

Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

November 14, 2018

Last Update Submit

December 6, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Measured in %point
From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks)

Secondary Outcomes (9)

Change in total insulin dose
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in basal insulin dose
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in prandial insulin dose
From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Change in local laboratory measured fasting plasma glucose (FPG)
From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
The incidence of patient recollection of non-severe hypoglycaemic episodes
Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
+4 more secondary outcomes

Study Arms (1)

Patients with Type 2 Diabetes requiring insulin therapy

Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)

Drug: Insulin Degludec/Insulin Aspart

Interventions

Insulin Degludec/Insulin AspartDRUG

Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan

Patients with Type 2 Diabetes requiring insulin therapy

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

Patients with type 2 diabetes requiring insulin therapy

You may qualify if:

Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol
The decision to initiate treatment with commercially available insulin Ryzodeg® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study
Male or female, age more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent
Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent
Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment
For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg®

You may not qualify if:

Previous participation in this study. Participation is defined as signed informed consent.
Pregnancy
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Hypersensitivity to Ryzodeg® or to any of the excipients
Previously treated with Ryzodeg®

Contact the study team to confirm eligibility.