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NCT02230618 Clinical Trial

Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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 Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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 NCT02230618
Other study ID # NN5401-4149
Secondary ID U1111-1157-0615E
Status Completed
Phase N/A
First received August 29, 2014
Last updated March 12, 2018
Start date November 24, 2015
Est. completion date June 1, 2017

Study information
Verified date March 2018
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 this study is to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.

Recruitment information / eligibility
Status Completed
Enrollment 1029
Est. completion date June 1, 2017
Est. primary completion date June 1, 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 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Amritsar Punjab
India Novo Nordisk Investigational Site Angamaly Kerala
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bilaspur
India Novo Nordisk Investigational Site Chandigarh Punjab
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 Gandhinagar Gujarat
India Novo Nordisk Investigational Site Ghuma Gujarat
India Novo Nordisk Investigational Site Guntur Andhra Pradesh
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Jaipur Rajasthan
India Novo Nordisk Investigational Site Jaipur Rajasthan
India Novo Nordisk Investigational Site Kochi Kerala
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Lucknow Uttar Pradesh
India Novo Nordisk Investigational Site Lucknow Uttar Pradesh
India Novo Nordisk Investigational Site Madurai Tamil Nadu
India Novo Nordisk Investigational Site Mangalore Karnataka
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site Noida Uttar Pradesh
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Surat Gujarat
India Novo Nordisk Investigational Site Thriruvananthapuram
India Novo Nordisk Investigational Site Thrissur Kerala
India Novo Nordisk Investigational Site Trivandrum Kerala
India Novo Nordisk Investigational Site Vijayawada Andhra Pradesh
India Novo Nordisk Investigational Site Visakhapatnam 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) Weeks 0-52
Secondary Serious Adverse Events (SAEs) Weeks 0-52
Secondary Serious Adverse Drug Reactions (SADRs) Weeks 0-52
Secondary Adverse Drug Reactions (ADRs) Weeks 0-52
Secondary Severe or Blood glucose (BG) Confirmed hypoglycaemia Weeks 0-52
Secondary Change in HbA1c (glycosylated haemoglobin) Week 0, week 52
Secondary Change in Fasting Plasma Glucose (FPG) Week 0, week 52
Secondary Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) Week 0, week 52
Secondary The reason for initiating or intensifying treatment with Ryzodeg™ Week 0 - week 52
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