A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Phase 4

• Conditions: Health Condition 1: null- Diabetes MellitusHealth Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2015/12/006436
• Lead Sponsor: ovo Nordisk India Private Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g., HbA1c, FPG, severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data.

2. Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician.

Exclusion Criteria

1. Known or suspected allergy to Tresiba®, the active substance 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 Tresiba® 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