Diabetes Mellitus, Type 2RESILIENTNCT03745157
RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Degludec/Insulin Aspart
- How many people
- 246 participants
- Where
- 29 sitesJapan
- Study dates
- 21 Nov 2018to 29 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes requiring insulin therapy
Who may be able to join
- 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®
Who cannot join
- 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®
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Novo Nordisk Investigational Site
Arakawa-ku, Tokyo, 116-0012
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103-0002
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, 819-0006
Novo Nordisk Investigational Site
Fukushima, 963-8851
Novo Nordisk Investigational Site
Higashiosaka-shi, Osaka
Novo Nordisk Investigational Site
Hokkaido, 062-0007
Novo Nordisk Investigational Site
Hosu-gun, Ishikawa, 927-0053
Novo Nordisk Investigational Site
Kanagawa, 235-0045
Novo Nordisk Investigational Site
Kanagawa, 247-0055
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, 350-0851
Novo Nordisk Investigational Site
Kawaguchi-shi, Saitama, 332-0012
Novo Nordisk Investigational Site
Kisarazu-shi, Chiba, 292-0038
Novo Nordisk Investigational Site
Kita-ku, Tokyo, 114-0001
Novo Nordisk Investigational Site
Nagano, 390-8621
Novo Nordisk Investigational Site
Saitama-shi, Saitama, 336-0963
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060-0001
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, 980-0021
Novo Nordisk Investigational Site
Shimotsuga-gun, Tochigi, 321-0204
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329-0433
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, 160-0023
Novo Nordisk Investigational Site
Shizuoka-city, Shizuoka, 420-8630
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, 420-0923
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, 424-0853
Novo Nordisk Investigational Site
Tochigi, 323-0022
Novo Nordisk Investigational Site
Tokyo, 113-8431
Novo Nordisk Investigational Site
Tokyo, 143-8541
Novo Nordisk Investigational Site
Tsuchiura-shi,Ibaraki, 300-0062
Novo Nordisk Investigational Site
Yaizu-shi, Shizuoka, 425-0022
Novo Nordisk Investigational Site
Yokohama-shi, Kanagawa, 223-0066
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Degludec/Insulin Aspart
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Insulin Degludec/Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Measured in %point
Measured: 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
Measured in units/day
Measured: 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
Measured in units/day
Measured: 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
Measured in units/day
Measured: 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)
Measured in mg/dL
Measured: 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
Measured in episodes/person-year
Measured: 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)
The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes
Measured in episodes/person-year
Measured: 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)
The incidence of patient recollection of overall severe hypoglycaemic episodes
Measured in episodes/person-year
Measured: 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)
The incidence of patient recollection of nocturnal severe hypoglycaemic episodes
Measured in episodes/person-year
Measured: 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)
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))
Measured: From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start21 Nov 2018
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745157
- Sponsor's protocol ID
- NN5401-4441
- Other IDs
- U1111-1208-5143
- Acronym
- RESILIENT
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2018
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 34304385
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03745157
- Acronym / sponsor ID
- RESILIENT / NN5401-4441
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes requiring insulin therapy | – | Drug: Insulin Degludec/Insulin AspartPatients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes requiring insulin therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Degludec/Insulin AspartPatients 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 | Drug | Patients with Type 2 Diabetes requiring insulin therapy |
Primary outcome
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Time frame: 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
9 secondary outcomes
Change in total insulin dose
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes
Time frame: 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)
The incidence of patient recollection of overall severe hypoglycaemic episodes
Time frame: 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)
The incidence of patient recollection of nocturnal severe hypoglycaemic episodes
Time frame: 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)
Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL)
Time frame: From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 34304385Shigiyama 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in local laboratory measured glycosylated haemoglobin (HbA1c) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03745157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.