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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01984372
• Collaborator: (none)
• Enrollment: 6,163
• Location: 1
• Actual Duration (Months): 65.7
• Patients Per Site Per Month: 93.7

Study Details

Study Description

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	Phase
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2	Drug: insulin degludec

Study Design

• Study Type: Observational
• Actual Enrollment: 6163 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
• Actual Study Start Date: Nov 6, 2013
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Incidence of AEs (Adverse Events) by preferred term [During 3 years of treatment]

Secondary Outcome Measures

1. Incidence of AEs (Adverse Events) by preferred term [During 6 months of treatment]

2. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [During 6 months of treatment]

3. Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term [During 3 years of treatment]

4. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [During 6 months of treatment]

5. Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term [During 3 years of treatment]

6. Incidence of severe hypoglycaemia [During 6 months of treatment]

7. Incidence of severe hypoglycaemia [During 3 years of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tokyo		Japan	1000005

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01984372
• Other Study ID Numbers: NN1250-4061; U1111-1144-4412
• First Posted: Nov 14, 2013
• Last Update Posted: Aug 4, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Insulin

Study Results

No Results Posted as of Aug 4, 2020