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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multi-centre, Prospective, Open-label, Single-arm, 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03070704
• Other study ID #: NN9068-4331
• Secondary ID: U1111-1185-0871
• Status: Withdrawn
• Phase: N/A
• First received: February 24, 2017
• Last updated: September 1, 2017
• Start date: August 16, 2017
• Est. completion date: August 16, 2019

Study information

• Verified date: August 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/liraglutide
Patients will be treated with commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent Adverse Events (AEs)	Count and % of events	Year 0-1
Secondary	Number of Serious Adverse Events (SAEs)	Count and % of events	Year 0-1
Secondary	Number of Serious Adverse Drug Reactions (SADRs)	Count and % of events	Year 0-1
Secondary	Number of Adverse Drug Reactions (ADRs)	Count and % of events	Year 0-1
Secondary	Number of confirmed hypoglycaemic episodes	Count of episodes	Year 0-1
Secondary	Change from baseline in the level of glycosylated haemoglobin (HbA1c)	Measured in %	Year 0, Year 1
Secondary	Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline	Measured in mg/dl or other equivalent SI units	Year 0, Year 1
Secondary	Percentage of patients achieving the target level of HbA1c below 7%	Measured in %	Year 1
Secondary	Change in body weight	Measured in kg and/or %	Year 0, Year 1
Secondary	Number of patients withdrawn due to ineffective therapy	Count of withdrawals	Year 1