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

NCT01984372 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6163

Last updated 2020-08-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin degludec

Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-06
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984372 on ClinicalTrials.gov