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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Degludec/Insulin Aspart

• Registration Number: NCT03745157
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-19
• Study Start: 2018-11-21
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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®

Read More

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®

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Type 2 Diabetes requiring insulin therapy	Insulin Degludec/Insulin Aspart	Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar)

Primary Outcome Measures

Name	Time	Method
Change in local laboratory measured glycosylated haemoglobin (HbA1c)	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)	Measured in %point

Secondary Outcome Measures

Name	Time	Method
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)	Measured in mg/dL
The incidence of patient recollection of nocturnal 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)	Measured in episodes/person-year
The incidence of patient recollection of overall severe hypoglycaemic episodes	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)	Measured in episodes/person-year
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)	Measured in units/day
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)	Measured in units/day
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)	Measured in units/day
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)	Measured in episodes/person-year
The incidence of patient recollection of nocturnal severe hypoglycaemic episodes	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)	Measured in episodes/person-year
Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)	From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)	Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL))

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Yokohama-shi, Kanagawa, Japan