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NCT02117622 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02117622
Other study ID # NN1250-4129
Secondary ID U1111-1145-9828E
Status Completed
Phase N/A
First received April 16, 2014
Last updated August 1, 2017
Start date July 24, 2015
Est. completion date April 5, 2017

Study information
Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1056
Est. completion date April 5, 2017
Est. primary completion date April 5, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• insulin degludec
Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study

Locations
Country Name City State
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bhopal Madhya Pradesh
India Novo Nordisk Investigational Site Chennai
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Coimbatore Tamil Nadu
India Novo Nordisk Investigational Site Coimbatore Tamil Nadu
India Novo Nordisk Investigational Site Delhi New Delhi
India Novo Nordisk Investigational Site Delhi New Delhi
India Novo Nordisk Investigational Site Ghuma Gujarat
India Novo Nordisk Investigational Site Guntur Andhra Pradesh
India Novo Nordisk Investigational Site Gurgaon Haryana
India Novo Nordisk Investigational Site Guwahati Assam
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Hyderabad Andhra Pradesh
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Madurai Tamil Nadu
India Novo Nordisk Investigational Site Mohali Punjab
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site Nagpur Maharashtra
India Novo Nordisk Investigational Site New Delhi
India Novo Nordisk Investigational Site Noida Uttar Pradesh
India Novo Nordisk Investigational Site Noida Uttar Pradesh
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Thriruvananthapuram
India Novo Nordisk Investigational Site Thrissur Kerala
India Novo Nordisk Investigational Site Vijayawada Andhra Pradesh

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) by preferred term During 1 year of treatment
Secondary Incidence of serious adverse events (SAEs) by preferred term During 1 year of treatment
Secondary Incidence of serious adverse drug reactions (SADRs) by preferred term During 1 year of treatment
Secondary Incidence of adverse drug reactions (ADRs) by preferred term During 1 year of treatment
Secondary Incidence of severe hypoglycaemia During 1 year of treatment
Secondary Change from baseline in glycosylated haemoglobin (HbA1c) Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Secondary Change from baseline in fasting plasma glucose (FPG) Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Secondary Incidence of confirmed hypoglycaemia During 1 year of treatment
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