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

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 - Ryzodeg PMS study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/12/006442

Enrollment

1000

Registered

2015-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus

Interventions

Intervention1: RyzodegTM FlexTouchTM in a prefilled pen injector (100 U/mL): Insulin degludec/ insulin aspart for once or twice daily subcutaneous injection or as per prescribing information 52 weeks

Eligibility

Inclusion criteria

Inclusion criteria: "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"

Exclusion criteria

Exclusion criteria: "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"

Design outcomes

Primary

Measure	Time frame
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. Timepoint: 1 year	—

Secondary

Measure	Time frame
To assess efficacy and additional safety of long term (1 year) treatment with Ryzodegâ?¢ Timepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Bharathi R

Novo Nordisk India Pvt Ltd

mvsr@novonordisk.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026