Trials / Completed
CompletedNCT03416855
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
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 768 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin degludec /insulin aspart | Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician. |
Timeline
- Start date
- 2018-01-31
- Primary completion
- 2020-05-19
- Completion
- 2020-05-19
- First posted
- 2018-01-31
- Last updated
- 2021-11-10
Locations
27 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03416855. Inclusion in this directory is not an endorsement.