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
- Conditions
- Diabetes Mellitus, Type 1DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02117622
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1056
Inclusion Criteria
- Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data
- Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician
Exclusion Criteria
- Known or suspected allergy to Tresiba®, the active substance or any of the excipients
- Previous participation in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who are or have previously been on Tresiba® therapy
- Patients who are participating in other studies or clinical trials
- Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with diabetes mellitus requiring insulin therapy insulin degludec -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) by preferred term During 1 year of treatment
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) by preferred term During 1 year of treatment Incidence of serious adverse drug reactions (SADRs) by preferred term During 1 year of treatment Incidence of adverse drug reactions (ADRs) by preferred term During 1 year of treatment Incidence of severe hypoglycaemia During 1 year of treatment Change from baseline in glycosylated haemoglobin (HbA1c) Baseline (Visit 1, week 0), end of study (Visit 4, week 52) Change from baseline in fasting plasma glucose (FPG) Baseline (Visit 1, week 0), end of study (Visit 4, week 52) Incidence of confirmed hypoglycaemia During 1 year of treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇳Thriruvananthapuram, India