Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

Novo Nordisk

Status: Withdrawn

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec/liraglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT03070704

NN9068-4331

U1111-1185-0871 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Asia. The aim of this study is to evaluate long term safety and efficacy in patients with type 2 diabetes mellitus in routine clinical practice in India.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)
• The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
• Male or female, age at least 18 years at the time of signing the informed consent
• Patients diagnosed with type 2 diabetes mellitus
• Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician

Exclusion criteria

• Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products
• Previous participation in this study. Participation is defined as signed informed consent
• Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
• Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months
• Patients who are participating in other studies or clinical trials.
• Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol

Trial design

0 participants in 1 patient group

Insulin degludec /liraglutide

Treatment:

Drug: insulin degludec/liraglutide