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

Withdrawn

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/liraglutide

• Registration Number: NCT03070704
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Status Verified: 2017-08
• Study Start: 2017-08-16
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05
• Primary Completion: 2019-03-01
• Study Completion: 2019-08-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin degludec /liraglutide	insulin degludec/liraglutide	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent Adverse Events (AEs)	Year 0-1	Count and % of events

Secondary Outcome Measures

Name	Time	Method
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 Serious Adverse Events (SAEs)	Year 0-1	Count and % of events
Number of patients withdrawn due to ineffective therapy	Year 1	Count of withdrawals
Number of Serious Adverse Drug Reactions (SADRs)	Year 0-1	Count and % of events