Clinical trial NCT03745157: RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 246
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes requiring insulin therapy

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Change in local laboratory measured glycosylated haemoglobin (HbA1c)
timeFrame: 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:
measure: Change in total insulin dose
timeFrame: 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)
measure: Change in basal insulin dose
timeFrame: 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)
measure: Change in prandial insulin dose
timeFrame: 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)
measure: Change in local laboratory measured fasting plasma glucose (FPG)
timeFrame: From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)
measure: The incidence of patient recollection of non-severe hypoglycaemic episodes
timeFrame: 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)
measure: The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes
timeFrame: 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)
measure: The incidence of patient recollection of overall severe hypoglycaemic episodes
timeFrame: 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)
measure: The incidence of patient recollection of nocturnal severe hypoglycaemic episodes
timeFrame: 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)
measure: Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)
timeFrame: From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)
Other outcomes:
Locations:
city: Arakawa-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Higashiosaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Hosu-gun, Ishikawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawagoe-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawaguchi-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kisarazu-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Kita-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Nagano
country: Japan
facility: Novo Nordisk Investigational Site
city: Saitama-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sendai-shi, Miyagi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuga-gun, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-city, Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi, Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi, Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tsuchiura-shi,Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Yaizu-shi, Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Shigiyama F, Liu L, Nordahl H, Suzuki R, Yamamoto Y, Hirose T. A Real-World, Prospective, Non-interventional Study of Adults with T2D Switching to IDegAsp from Glargine U100 or U300 in Japan. Diabetes Ther. 2021 Sep;12(9):2405-2421. doi: 10.1007/s13300-021-01117-8. Epub 2021 Jul 25.