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Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®

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ClinicalTrials.gov Identifier: NCT02821052
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

Condition or disease Intervention/treatment
Diabetes Drug: insulin degludec/insulin aspart

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Study Type : Observational
Actual Enrollment : 1354 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : November 14, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
insulin degludec/insulin aspart Drug: insulin degludec/insulin aspart
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.




Primary Outcome Measures :
  1. Incidence of AEs (adverse event) [ Time Frame: Year 0-1 ]

Secondary Outcome Measures :
  1. Incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: Year 0-1 ]
  2. Severe hypoglycaemic episodes [ Time Frame: Year 0-1 ]
  3. Incidence of Serious allergic reactions (systemic or localized, including injection site reactions) [ Time Frame: Year 0-1 ]
  4. Change in Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 52 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Criteria

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
  • The decision to initiate treatment with commercially available Ryzodeg® 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
  • Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg®
  • Male or female, no age limitation

Exclusion Criteria:

  • Patients who are or have previously been treated with Ryzodeg®
  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • Patients with a history of hypersensitivity to study product components
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821052


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02821052     History of Changes
Other Study ID Numbers: NN5401-4152
U1111-1149-9518 ( Other Identifier: WHO )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs