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
- Conditions
- Health Condition 1: null- Diabetes MellitusHealth Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2015/12/006442
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 976
1. 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 Ryzodeg• therapy) can be used for baseline data
2. Patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with Ryzodeg• based on the clinical judgment of their treating physician.
3. More than 18 years old, male / female patients
1. Known or suspected allergy to Ryzodeg• 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.
4. Patients who are or have previously been on Ryzodeg• therapy.
5. 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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- 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. <br/ ><br>Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method To assess efficacy and additional safety of long term (1 year) treatment with Ryzodegâ?¢ <br/ ><br>Timepoint: 1 year