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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02821052
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date June 29, 2016
First Posted Date July 1, 2016
Last Update Posted Date October 15, 2019
Actual Study Start Date July 1, 2016
Actual Primary Completion Date November 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2016)
Incidence of AEs (adverse event) [ Time Frame: Year 0-1 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02821052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 29, 2016)
  • Incidence of SADRs (Serious Adverse Drug Reactions) [ Time Frame: Year 0-1 ]
  • Severe hypoglycaemic episodes [ Time Frame: Year 0-1 ]
  • Incidence of Serious allergic reactions (systemic or localized, including injection site reactions) [ Time Frame: Year 0-1 ]
  • Change in Glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 52 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®
Official Title Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.
Condition Diabetes
Intervention Drug: insulin degludec/insulin aspart
Enrolled patients will be treated with Ryzodeg® under routine clinical practice.
Study Groups/Cohorts insulin degludec/insulin aspart
Intervention: Drug: insulin degludec/insulin aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 14, 2019)
1355
Original Estimated Enrollment
 (submitted: June 29, 2016)
1250
Actual Study Completion Date November 24, 2018
Actual Primary Completion Date November 24, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02821052
Other Study ID Numbers NN5401-4152
U1111-1149-9518 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2019