Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India

March 12, 2018 updated by: Novo Nordisk A/S

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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 this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1029

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
      • Bilaspur, India, 495001
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Novo Nordisk Investigational Site
      • Vijayawada, Andhra Pradesh, India, 520002
        • Novo Nordisk Investigational Site
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India
        • Novo Nordisk Investigational Site
      • Gandhinagar, Gujarat, India, 382428
        • Novo Nordisk Investigational Site
      • Ghuma, Gujarat, India
        • Novo Nordisk Investigational Site
      • Surat, Gujarat, India, 395002
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India
        • Novo Nordisk Investigational Site
      • Mangalore, Karnataka, India, 575001
        • Novo Nordisk Investigational Site
    • Kerala
      • Angamaly, Kerala, India
        • Novo Nordisk Investigational Site
      • Kochi, Kerala, India, 682041
        • Novo Nordisk Investigational Site
      • Thrissur, Kerala, India
        • Novo Nordisk Investigational Site
      • Trivandrum, Kerala, India
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452008
        • Novo Nordisk Investigational Site
      • Indore, Madhya Pradesh, India
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
    • Punjab
      • Amritsar, Punjab, India
        • Novo Nordisk Investigational Site
      • Chandigarh, Punjab, India
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Novo Nordisk Investigational Site
      • Jaipur, Rajasthan, India
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600037
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600100
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India
        • 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
      • Lucknow, Uttar Pradesh, India, 226005
        • Novo Nordisk Investigational Site
      • Lucknow, Uttar Pradesh, India
        • Novo Nordisk Investigational Site
      • Noida, Uttar Pradesh, India, 201301
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes where the treating physician has decided to start Ryzodeg™ according to routine clinical practice will qualify for starting treatment with Ryzodeg™.

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. (Study-related activities are any procedures that are related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c (Glycated Haemoglobin ), FPG (Fasting Plasma Glucose), PPPG (Postprandial Plasma Glucose), severe hypoglycaemia before the start of Ryzodeg™ therapy) can be used for baseline data
  • Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg™ based on the clinical judgment of their treating physician

Exclusion Criteria:

  • Known or suspected allergy to Ryzodeg™ any of the active substances 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 Ryzodeg™ 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ryzodeg™
Drug: insulin degludec/insulin aspart
Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Weeks 0-52
Weeks 0-52

Secondary Outcome Measures

Outcome Measure
Time Frame
Serious Adverse Events (SAEs)
Time Frame: Weeks 0-52
Weeks 0-52
Serious Adverse Drug Reactions (SADRs)
Time Frame: Weeks 0-52
Weeks 0-52
Adverse Drug Reactions (ADRs)
Time Frame: Weeks 0-52
Weeks 0-52
Severe or Blood glucose (BG) Confirmed hypoglycaemia
Time Frame: Weeks 0-52
Weeks 0-52
Change in HbA1c (glycosylated haemoglobin)
Time Frame: Week 0, week 52
Week 0, week 52
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 52
Week 0, week 52
Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG)
Time Frame: Week 0, week 52
Week 0, week 52
The reason for initiating or intensifying treatment with Ryzodeg™
Time Frame: Week 0 - week 52
Week 0 - week 52

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)

November 24, 2015

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (ESTIMATE)

September 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4149
  • U1111-1157-0615 (OTHER: World Health Organization (WHO))
  • ENCEPP/SDPP/6587 (REGISTRY: 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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