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

August 1, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1056

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chennai, India, 600008
        • Novo Nordisk Investigational Site
      • New Delhi, India, 110088
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500072
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500004
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500001
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India
        • Novo Nordisk Investigational Site
      • Vijayawada, Andhra Pradesh, India, 520002
        • Novo Nordisk Investigational Site
    • Assam
      • Guwahati, Assam, India, 781006
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India
        • Novo Nordisk Investigational Site
      • Ghuma, Gujarat, India
        • Novo Nordisk Investigational Site
    • Haryana
      • Gurgaon, Haryana, India
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Novo Nordisk Investigational Site
    • Kerala
      • Thrissur, Kerala, India
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462037
        • Novo Nordisk Investigational Site
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
      • Indore, Madhya Pradesh, India
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Novo Nordisk Investigational Site
      • Nagpur, Maharashtra, India, 440010
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India
        • Novo Nordisk Investigational Site
    • New Delhi
      • Delhi, New Delhi, India, 110076
        • Novo Nordisk Investigational Site
      • Delhi, New Delhi, India
        • Novo Nordisk Investigational Site
    • Punjab
      • Mohali, Punjab, India, 160062
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600037
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600040
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600100
        • Novo Nordisk Investigational Site
      • Coimbatore, Tamil Nadu, India, 641018
        • Novo Nordisk Investigational Site
      • Coimbatore, Tamil Nadu, India, 641009
        • Novo Nordisk Investigational Site
      • Madurai, Tamil Nadu, India, 625 020
        • Novo Nordisk Investigational Site
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India, 201301
        • Novo Nordisk Investigational Site
      • Noida, Uttar Pradesh, India
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700094
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with diabetes mellitus requiring insulin therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs) by preferred term
Time Frame: During 1 year of treatment
During 1 year of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2015

Primary Completion (Actual)

April 5, 2017

Study Completion (Actual)

April 5, 2017

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4129
  • U1111-1145-9828 (Other Identifier: WHO)
  • ENCEPP/SDPP/6318 (Registry Identifier: EU PASS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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