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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 : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : September 15, 2016
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 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec

Study Type : Observational
Estimated Enrollment : 6000 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
Study Start Date : November 2013
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 ]


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

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

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 Posted: November 14, 2013    Key Record Dates
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