A Non-interventional, Post Marketing Surveillance (PMS) Study of Ryzodegâ„¢ (Insulin Degludec/ insulin aspart) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Not Applicable

Completed

Brief Summary: **A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India.**

Recruitment & 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, FPG, PPPG, severe hypoglycaemia before the start of Ryzodegâ„¢ therapy) can be used for baseline data 2.
Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodegâ„¢ based on the clinical judgment of their treating physician.
More than 18 years old, male / female patients".

Exclusion Criteria

Known or suspected allergy to Ryzodegâ„¢ any of the active substances or any of the excipients 2.
Previous participation in this study 3.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Patients who are or have previously been on Ryzodegâ„¢ therapy.
Patients who are participating in other studies or clinical trials 6.
Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months".

Primary Outcome Measures

Name	Time	Method
To assess the safety of long-term treatment with insulin degludec/ insulin aspart (Ryzodegâ„¢) in insulin requiring patients with diabetes mellitus, initiating treatment with Ryzodegâ„¢ under routine clinical practice in India.	1 year

Secondary Outcome Measures

Name	Time	Method
To assess efficacy and additional safety of long term (1 year) treatment with Ryzodegâ„¢

Locations (39): Ajanta Research Centre
🇮🇳
Lucknow, UTTAR PRADESH, India
Amandeep Hospital
🇮🇳
Amritsar, PUNJAB, India
Amrita institute of medical sciences and research centre
🇮🇳
Ernakulam, KERALA, India
Apollo Gleneagles Hospitals
🇮🇳
Kolkata, WEST BENGAL, India
Apollo gleneagles hospitals, Kolkata
🇮🇳
Kolkata, WEST BENGAL, India
Apollo hospitals
🇮🇳
Bilaspur, CHHATTISGARH, India
Apollo Hospitals International Limited
🇮🇳
Gandhinagar, GUJARAT, India
Asirvatham Hospitals
🇮🇳
Madurai, TAMIL NADU, India
Choithram Hospitals
🇮🇳
Indore, MADHYA PRADESH, India
Convenient Hospitals,
🇮🇳
Indore, MADHYA PRADESH, India
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Ajanta Research Centre
🇮🇳Lucknow, UTTAR PRADESH, India
Dr AK Awasthi
Principal investigator
9415063607
drakawasthi@gmail.com