A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus

Completed

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

• Registration Number: NCT02754817
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04-26
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Primary Completion: 2016-10-20
• Study Completion: 2016-10-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

• Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
• Male or female patients at least 18 years of age at time of informed consent
• Diagnosis of T2DM (type 2 diabetes mellitus)
• Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion
• Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value

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Exclusion Criteria

• Type 1 diabetes
• Previous participation in this study. Participation is defined as having provided informed consent
• Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria)
• Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation

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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
Change in HbA1c (Hemoglobin A1c)	week 0, week 26

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Month 0, month 3, month 9, months 12
Percentage of responders for HbA1c below 7 percent (53 mmol/mol)	At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain	At 3, 6, 9 and 12 months
Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes	At 3, 6, 9 and 12 months

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Stevenage, United Kingdom