Clinical trial NCT02117622: 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
Official title: A Multi-centre, Prospective, Open-label, Single-arm, 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 1056
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus requiring insulin therapy who qualify for starting treatment with Tresiba® based on the clinical judgment by their treating physician during enrolment period.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (AEs) by preferred term
timeFrame: During 1 year of treatment
Secondary outcomes:
measure: Incidence of serious adverse events (SAEs) by preferred term
timeFrame: During 1 year of treatment
measure: Incidence of serious adverse drug reactions (SADRs) by preferred term
timeFrame: During 1 year of treatment
measure: Incidence of adverse drug reactions (ADRs) by preferred term
timeFrame: During 1 year of treatment
measure: Incidence of severe hypoglycaemia
timeFrame: During 1 year of treatment
measure: Change from baseline in glycosylated haemoglobin (HbA1c)
timeFrame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
measure: Incidence of confirmed hypoglycaemia
timeFrame: During 1 year of treatment
Other outcomes:
Locations:
city: Guntur
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Guwahati
country: India
facility: Novo Nordisk Investigational Site
state: Assam
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ghuma
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Gurgaon
country: India
facility: Novo Nordisk Investigational Site
state: Haryana
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Thrissur
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Bhopal
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Indore
country: India
facility: Novo Nordisk Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Delhi
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Delhi
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Mohali
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Madurai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Noida
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Noida
country: India
facility: Novo Nordisk Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: