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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01984372
First received: November 7, 2013
Last updated: August 13, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of AEs (Adverse Events) by preferred term [ Time Frame: During 6 months of treatment ] [ Designated as safety issue: No ]
  • Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [ Time Frame: During 6 months of treatment ] [ Designated as safety issue: No ]
  • Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [ Time Frame: During 3 years of treatment ] [ Designated as safety issue: No ]
  • Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [ Time Frame: During 6 months of treatment ] [ Designated as safety issue: No ]
  • Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [ Time Frame: During 3 years of treatment ] [ Designated as safety issue: No ]
  • Incidence of severe hypoglycaemia [ Time Frame: During 6 months of treatment ] [ Designated as safety issue: No ]
  • Incidence of severe hypoglycaemia [ Time Frame: During 3 years of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: November 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01984372     History of Changes
Other Study ID Numbers: NN1250-4061, U1111-1144-4412
Study First Received: November 7, 2013
Last Updated: August 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014