Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Tresiba®
Completed
Novo Nordisk A/S
2013-11-06
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.
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
Completed
Novo Nordisk A/S
2015-07-24
This study is conducted in Asia. The aim of the study is to evaluate long term safety and
efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine
clinical practice in India.
Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia
Completed
Aarhus University Hospital
Phase 4
2015-01-01
The purpose of this study is to determine whether insulin degludec compared to insulin
glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the
greatest potential benefit from optimised insulin treatment, which are patients with type 1
diabetes and high risk of nocturnal severe hypoglycaemia.
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