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

NCT ID: NCT01984372

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-06

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tresiba® users

insulin degludec

Intervention Type DRUG

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

Interventions

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insulin degludec

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1144-4412

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-4061

Identifier Type: -

Identifier Source: org_study_id

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