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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03070704

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin degludec/liraglutide

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Aug 16, 2017

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Aug 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Insulin degludec /liraglutide	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

Arm

Intervention/Treatment

Insulin degludec /liraglutide

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

Outcome Measures

Primary Outcome Measures

Incidence of treatment emergent Adverse Events (AEs) [Year 0-1]
Count and % of events

Secondary Outcome Measures

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Number of patients withdrawn due to ineffective therapy [Year 1]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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03070704

Other Study ID Numbers:

NN9068-4331
U1111-1185-0871

First Posted:

Mar 3, 2017

Last Update Posted:

Sep 5, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Liraglutide

Xultophy

Study Results

No Results Posted as of Sep 5, 2017