Clinical trial NCT03070704: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment emergent Adverse Events (AEs)
timeFrame: Year 0-1
Secondary outcomes:
measure: Number of Serious Adverse Events (SAEs)
timeFrame: Year 0-1
measure: Number of Serious Adverse Drug Reactions (SADRs)
timeFrame: Year 0-1
measure: Number of Adverse Drug Reactions (ADRs)
timeFrame: Year 0-1
measure: Number of confirmed hypoglycaemic episodes
timeFrame: Year 0-1
measure: Change from baseline in the level of glycosylated haemoglobin (HbA1c)
timeFrame: Year 0, Year 1
measure: Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline
timeFrame: Year 0, Year 1
measure: Percentage of patients achieving the target level of HbA1c below 7%
timeFrame: Year 1
measure: Change in body weight
timeFrame: Year 0, Year 1
measure: Number of patients withdrawn due to ineffective therapy
timeFrame: Year 1
Other outcomes:
Locations:
Study officials:
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