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

Diabetes Mellitus, Type 2 Clinical Trial

— RESILIENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03745157
• Other study ID #: NN5401-4441
• Secondary ID: U1111-1208-5143
• Status: Completed
• Start date: November 21, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: December 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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®

Exclusion Criteria:

• 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®

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Degludec/Insulin Aspart
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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Arakawa-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Chuo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Fukushima
Japan	Novo Nordisk Investigational Site	Higashiosaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Hokkaido
Japan	Novo Nordisk Investigational Site	Hosu-gun, Ishikawa
Japan	Novo Nordisk Investigational Site	Kanagawa
Japan	Novo Nordisk Investigational Site	Kanagawa
Japan	Novo Nordisk Investigational Site	Kawagoe-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kawaguchi-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kisarazu-shi, Chiba
Japan	Novo Nordisk Investigational Site	Kita-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Nagano
Japan	Novo Nordisk Investigational Site	Saitama-shi, Saitama
Japan	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Sendai-shi, Miyagi
Japan	Novo Nordisk Investigational Site	Shimotsuga-gun, Tochigi
Japan	Novo Nordisk Investigational Site	Shimotsuke-shi, Tochigi
Japan	Novo Nordisk Investigational Site	Shinjuku-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Shizuoka-city, Shizuoka
Japan	Novo Nordisk Investigational Site	Shizuoka-shi, Shizuoka
Japan	Novo Nordisk Investigational Site	Shizuoka-shi, Shizuoka
Japan	Novo Nordisk Investigational Site	Tochigi
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tsuchiura-shi,Ibaraki
Japan	Novo Nordisk Investigational Site	Yaizu-shi, Shizuoka
Japan	Novo Nordisk Investigational Site	Yokohama-shi, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in total insulin dose	Measured in units/day	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)
Secondary	Change in basal insulin dose	Measured in units/day	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)
Secondary	Change in prandial insulin dose	Measured in units/day	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)
Secondary	Change in local laboratory measured fasting plasma glucose (FPG)	Measured in mg/dL	From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
Secondary	The incidence of patient recollection of non-severe hypoglycaemic episodes	Measured in episodes/person-year	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)
Secondary	The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes	Measured in episodes/person-year	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)
Secondary	The incidence of patient recollection of overall severe hypoglycaemic episodes	Measured in episodes/person-year	Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Secondary	The incidence of patient recollection of nocturnal severe hypoglycaemic episodes	Measured in episodes/person-year	Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)
Secondary	Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)	Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL))	From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)