A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 27 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being tested?: Insulin degludec /insulin aspart
How many people: 768 participants
Where: 27 sitesSouth Korea
Study dates: 31 Jan 2018to 19 May 2020
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with diabetes mellitus, who are scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information

Inclusion Criteria: - The decision to initiate treatment with commercially available Ryzodeg® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI) Exclusion Criteria: - Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

South Korea27 sites

Novo Nordisk Investigational Site
Busan, 47392
Novo Nordisk Investigational Site
Busan, 48108
Novo Nordisk Investigational Site
Busan, 48575
Novo Nordisk Investigational Site
Busan, 49267
Novo Nordisk Investigational Site
Daegu, 42601
Novo Nordisk Investigational Site
Daejeon, 330-721
Novo Nordisk Investigational Site
Daejeon, 35015
Novo Nordisk Investigational Site
Daejeon, 361-711
Novo Nordisk Investigational Site
Gangwon-do, 26426
Novo Nordisk Investigational Site
Goyang, 410-719
Novo Nordisk Investigational Site
Gyeonggi-do, 10475
Novo Nordisk Investigational Site
Gyeonggi-do, 14068
Novo Nordisk Investigational Site
Gyeonggi-do, 14584
Novo Nordisk Investigational Site
Gyeonggi-do, 14754
Novo Nordisk Investigational Site
Incheon, 22332
Novo Nordisk Investigational Site
Jeonju, 54987
Novo Nordisk Investigational Site
Jeonju, 561-712
Novo Nordisk Investigational Site
Pusan, 602-739
Novo Nordisk Investigational Site
Seoul, 01450
Novo Nordisk Investigational Site
Seoul, 04401
Novo Nordisk Investigational Site
Seoul, 04564
Novo Nordisk Investigational Site
Seoul, 05355
Novo Nordisk Investigational Site
Seoul, 07354
Novo Nordisk Investigational Site
Seoul, 139-827
Novo Nordisk Investigational Site
Suwon, 16499
Novo Nordisk Investigational Site
Suwon-si, Gyeonggi-do, 16247
Novo Nordisk Investigational Site
Ulsan, 682-060

Other trials in South Korea

About this study

Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance(rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

Conditions: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Being tested: Insulin degludec /insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1, 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
Also called Ryzodeg® FlexTouch®
Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.

Study groups in NCT03416855
Study group	Role	What they receive
Overall population		Participants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management. Receives: Drug: Insulin degludec /insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Adverse events (AEs) at week 13
Count of events
Measured: week 13 (± 2 weeks)
Number of patients with AEs at week 13
Number of patients
Measured: week 13 (± 2 weeks)
Percentage of patients with AEs at week 13
Percentage of patients
Measured: week 13 (± 2 weeks)
Number of Adverse events (AEs) at week 26
Count of events
Measured: week 26 (± 2 weeks)
Number of patients with AEs at week 26
Number of patients
Measured: week 26 (± 2 weeks)
Percentage of patients with AEs at week 26
Percentage of patients
Measured: week 26 (± 2 weeks)

Secondary outcomes (28)

Number of patients with Adverse Drug Reaction (ADR) at week 13
Number of patients
Measured: week 13 (± 2 weeks)
Percentage of Patients with ADR at week 13
Percentage of patients
Measured: week 13 (± 2 weeks)
Number of Patients with ADR at week 26
Number of patients
Measured: week 26 (± 2 weeks)
Percentage of Patients with ADR at week 26
Percentage of patients
Measured: week 26 (± 2 weeks)
Number of patients with Serious AE/ADR at week 13
Number of patients
Measured: week 13 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 13
Percentage of patients
Measured: week 13 (± 2 weeks)
Number of patients with Serious AE/ADR at week 26
Number of patients
Measured: week 26 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 26
Percentage of patients
Measured: week 26 (± 2 weeks)
Number of patients with unexpected ADR at week 13
Number of patients
Measured: week 13 (± 2 weeks)
Percentage of patients with unexpected ADR at week 13
Percentage of patients
Measured: week 13 (± 2 weeks)
Number of subjects with unexpected ADR at week 26
Number of subjects
Measured: week 26 (± 2 weeks)
Percentage of patients with unexpected ADR at week 26
Percentage of patients
Measured: week 26 (± 2 weeks)
Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Number of patients
Measured: week 13 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Percentage of patients
Measured: week 13 (± 2 weeks)
Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Number of patients
Measured: week 26 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Percentage of patients
Measured: week 26 (± 2 weeks)
Change from baseline in body weight at week 13
Measured in kg
Measured: week 0, week 13 (± 2 weeks)
Change from baseline in body weight at week 26
Measured in kg
Measured: week 0, week 26 (± 2 weeks)
Insulin dose at week 13
Dose in Units
Measured: week 13 (± 2 weeks)
Insulin dose at week 26
Dose in Units
Measured: week 26 (± 2 weeks)
Change from baseline in HbA1c after 13 weeks of treatment
Measured in %
Measured: week 0, week 13 (± 2 weeks)
Change from baseline in HbA1c after 26 weeks of treatment
Measured in %
Measured: week 0, week 26 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment
Percentage of patients
Measured: week 13 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment
Percentage of patients
Measured: week 26 (± 2 weeks)
Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment
Measured in mg/dl or other equivalent SI units
Measured: week 0, week 13 (± 2 weeks)
Change from baseline in FBG/FPG after 26 weeks treatment
Measured in mg/dl or other equivalent SI units
Measured: week 0, week 26 (± 2 weeks)
Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment
Measured in mg/dl or other equivalent SI units
Measured: week 0, week 13 (± 2 weeks)
Changes from baseline in PPBG/PPPG after 26 weeks treatment
Measured in mg/dl or other equivalent SI units
Measured: week 0, week 26 (± 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 201819 May 2020

First posted31 Jan 2018
Study start31 Jan 2018
Primary completion19 May 2020
Study completion19 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DiabetesStudies 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: 768 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416855
Sponsor's protocol ID: NN5401-4196
Other IDs: 1111-1194-8505
Status last verified: Nov 2021
First submitted: 24 Jan 2018
Last updated: 10 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance(rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea
ClinicalTrials.gov ID: NCT03416855
Acronym / sponsor ID: NN5401-4196
Conditions: Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 768 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 31 Jan 2018 (actual)
Primary completion: 19 May 2020 (actual)
Study completion: 19 May 2020 (actual)
First posted: 31 Jan 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Overall population	–	Drug: Insulin degludec /insulin aspartParticipants will be decided to be treated with Ryzodeg® FlexTouch® by physicians before the enrolment in the study based on clinical judgement in the diabetes management.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with diabetes mellitus, who are scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information

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 aspartAlso: Ryzodeg® FlexTouch®Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.	Drug	Overall population

Primary outcome

Number of Adverse events (AEs) at week 13
Time frame: week 13 (± 2 weeks)
Count of events
Number of patients with AEs at week 13
Time frame: week 13 (± 2 weeks)
Number of patients
Percentage of patients with AEs at week 13
Time frame: week 13 (± 2 weeks)
Percentage of patients
Number of Adverse events (AEs) at week 26
Time frame: week 26 (± 2 weeks)
Count of events
Number of patients with AEs at week 26
Time frame: week 26 (± 2 weeks)
Number of patients
Percentage of patients with AEs at week 26
Time frame: week 26 (± 2 weeks)
Percentage of patients

28 secondary outcomes

Number of patients with Adverse Drug Reaction (ADR) at week 13
Time frame: week 13 (± 2 weeks)
Percentage of Patients with ADR at week 13
Time frame: week 13 (± 2 weeks)
Number of Patients with ADR at week 26
Time frame: week 26 (± 2 weeks)
Percentage of Patients with ADR at week 26
Time frame: week 26 (± 2 weeks)
Number of patients with Serious AE/ADR at week 13
Time frame: week 13 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 13
Time frame: week 13 (± 2 weeks)
Number of patients with Serious AE/ADR at week 26
Time frame: week 26 (± 2 weeks)
Percentage of patients with Serious AE/ADR at week 26
Time frame: week 26 (± 2 weeks)
Number of patients with unexpected ADR at week 13
Time frame: week 13 (± 2 weeks)
Percentage of patients with unexpected ADR at week 13
Time frame: week 13 (± 2 weeks)
Number of subjects with unexpected ADR at week 26
Time frame: week 26 (± 2 weeks)
Percentage of patients with unexpected ADR at week 26
Time frame: week 26 (± 2 weeks)
Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Time frame: week 13 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13
Time frame: week 13 (± 2 weeks)
Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Time frame: week 26 (± 2 weeks)
Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26
Time frame: week 26 (± 2 weeks)
Change from baseline in body weight at week 13
Time frame: week 0, week 13 (± 2 weeks)
Change from baseline in body weight at week 26
Time frame: week 0, week 26 (± 2 weeks)
Insulin dose at week 13
Time frame: week 13 (± 2 weeks)
Insulin dose at week 26
Time frame: week 26 (± 2 weeks)
Change from baseline in HbA1c after 13 weeks of treatment
Time frame: week 0, week 13 (± 2 weeks)
Change from baseline in HbA1c after 26 weeks of treatment
Time frame: week 0, week 26 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment
Time frame: week 13 (± 2 weeks)
Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment
Time frame: week 26 (± 2 weeks)
Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment
Time frame: week 0, week 13 (± 2 weeks)
Change from baseline in FBG/FPG after 26 weeks treatment
Time frame: week 0, week 26 (± 2 weeks)
Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment
Time frame: week 0, week 13 (± 2 weeks)
Changes from baseline in PPBG/PPPG after 26 weeks treatment
Time frame: week 0, week 26 (± 2 weeks)

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 10 Nov 2021.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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

27 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 and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 27 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in South Korea. 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?

Number of Adverse events (AEs) at week 13 (time frame: week 13 (± 2 weeks)). The study lists 6 primary outcomes in all. 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 NCT03416855.

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 10 Nov 2021.