NCT03070704WithdrawnNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Novo Nordisk A/S
- Primary Endpoint
- Incidence of treatment emergent Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Insulin degludec /liraglutide
Intervention: insulin degludec/liraglutide (Drug)
Outcomes
Primary Outcomes
Incidence of treatment emergent Adverse Events (AEs)
Time Frame: Year 0-1
Count and % of events
Secondary Outcomes
- Number of Adverse Drug Reactions (ADRs)(Year 0-1)
- Number of confirmed hypoglycaemic episodes(Year 0-1)
- Change from baseline in the level of glycosylated haemoglobin (HbA1c)(Year 0, Year 1)
- Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline(Year 0, Year 1)
- Percentage of patients achieving the target level of HbA1c below 7%(Year 1)
- Change in body weight(Year 0, Year 1)
- Number of Serious Adverse Events (SAEs)(Year 0-1)
- Number of patients withdrawn due to ineffective therapy(Year 1)
- Number of Serious Adverse Drug Reactions (SADRs)(Year 0-1)
Investigators
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