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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01984372
First Posted: November 14, 2013
Last Update Posted: September 15, 2016
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

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 Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

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

Estimated Enrollment: 6000
Study Start Date: November 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tresiba® users Drug: insulin degludec
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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 Submitted: November 7, 2013
First Posted: November 14, 2013
Last Update Posted: September 15, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs