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

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ClinicalTrials.gov Identifier: NCT01984372
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This study is conducted in Asia. The aim of this post marketing surveillance (PMS) is to assess safety and effectiveness of long-term treatment with Tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

A total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of Tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the PMS more precisely. At the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec

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Study Type : Observational
Actual Enrollment : 6165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre, Open Label, Observational, Non-interventional, Post Marketing Surveillance to Evaluate Safety and Effectiveness During Long-term Treatment With Tresiba® (Insulin Degludec) in Patients With Diabetes Mellitus Requiring Insulin Therapy Under Normal Clinical Practice Conditions
Actual Study Start Date : November 6, 2013
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tresiba® users Drug: insulin degludec
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.




Primary Outcome Measures :
  1. Incidence of AEs (Adverse Events) by preferred term [ Time Frame: During 3 years of treatment ]

Secondary Outcome Measures :
  1. Incidence of AEs (Adverse Events) by preferred term [ Time Frame: During 6 months of treatment ]
  2. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [ Time Frame: During 6 months of treatment ]
  3. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [ Time Frame: During 3 years of treatment ]
  4. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [ Time Frame: During 6 months of treatment ]
  5. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [ Time Frame: During 3 years of treatment ]
  6. Incidence of severe hypoglycaemia [ Time Frame: During 6 months of treatment ]
  7. Incidence of severe hypoglycaemia [ Time Frame: During 3 years of treatment ]


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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
Patients with diabetes mellitus requiring insulin therapy not previously treated with Tresiba®, including newly-diagnosed patients whom the physician has judged as appropriate to start treatment with Tresiba®.
Criteria

Inclusion Criteria:

  • Patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start Tresiba® treatment

Exclusion Criteria:

  • Patients who are or have previously been on Tresiba® therapy
  • Patients who have previously been participating in this PMS

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): NCT01984372


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: NCT01984372     History of Changes
Other Study ID Numbers: NN1250-4061
U1111-1144-4412 ( Other Identifier: WHO )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs