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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin degludec/liraglutide

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent Adverse Events (AEs)	Count and % of events	Year 0-1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serious Adverse Events (SAEs)	Count and % of events	Year 0-1
Number of Serious Adverse Drug Reactions (SADRs)	Count and % of events	Year 0-1
Number of Adverse Drug Reactions (ADRs)	Count and % of events	Year 0-1
Number of confirmed hypoglycaemic episodes	Count of episodes	Year 0-1
Change from baseline in the level of glycosylated haemoglobin (HbA1c)	Measured in %	Year 0, Year 1
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
Percentage of patients achieving the target level of HbA1c below 7%	Measured in %	Year 1
Change in body weight	Measured in kg and/or %	Year 0, Year 1
Number of patients withdrawn due to ineffective therapy	Count of withdrawals	Year 1

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Anticipated): August 16, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): August 16, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Xultophy
• Other Study ID Numbers: NN9068-4331; U1111-1185-0871 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No