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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/12/006436

Enrollment

1000

Registered

2015-12-11

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: Tresiba FlexTouch prefilled pen injector 100 U/mL.: Insulin degludec for once daily subcutaneous injection or as per prescribing information. 52 weeks Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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 TresibaÂ® therapy) can be used for baseline data. 2. Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with TresibaÂ® based on the clinical judgment of their treating physician.

Exclusion criteria

Exclusion criteria: 1. Known or suspected allergy to TresibaÂ®, 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 TresibaÂ® 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 (TresibaÂ®) in insulin requiring patients with diabetes mellitus, initiating treatment with TresibaÂ® under routine clinical practice in India.Timepoint: To assess the safety of long-term treatment with insulin degludec (TresibaÂ®) in insulin requiring patients with diabetes mellitus, initiating treatment with TresibaÂ® under routine clinical practice in India.	—

Measure

Time frame

To assess the safety of long-term treatment with insulin degludec (TresibaÂ®) in insulin requiring patients with diabetes mellitus, initiating treatment with TresibaÂ® under routine clinical practice in India.Timepoint: To assess the safety of long-term treatment with insulin degludec (TresibaÂ®) in insulin requiring patients with diabetes mellitus, initiating treatment with TresibaÂ® under routine clinical practice in India.

—

Secondary

Measure	Time frame
To assess safety and efficacy of long term (1 year) treatment with TresibaÂ®Timepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Rajkumar C

Novo Nordisk India Private Ltd

rjg@novonordisk.com918040303200

Outcome results

None listed

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