Overview

This trial is active, not recruiting.

Conditions diabetes, diabetes mellitus, type 1, diabetes mellitus, type 2
Treatment insulin degludec
Sponsor Novo Nordisk A/S
Start date November 2013
End date April 2019
Trial size 6000 participants
Trial identifier NCT01984372, NN1250-4061, U1111-1144-4412

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
insulin degludec
Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.

Primary Outcomes

Measure
Incidence of AEs (Adverse Events) by preferred term
time frame: During 3 years of treatment

Secondary Outcomes

Measure
Incidence of AEs (Adverse Events) by preferred term
time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
time frame: During 6 months of treatment
Incidence of SADRs (Serious Adverse Drug Reactions) by preferred term
time frame: During 3 years of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
time frame: During 6 months of treatment
Incidence of serious allergic reactions (systemic or localized, including injection site reactions) by preferred term
time frame: During 3 years of treatment
Incidence of severe hypoglycaemia
time frame: During 6 months of treatment
Incidence of severe hypoglycaemia
time frame: During 3 years of treatment

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.