A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
January 11, 2018 updated by: Novo Nordisk A/S
A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
611
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wien, Austria, 1130
- Novo Nordisk Investigational Site
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Leipzig, Germany, 04103
- Novo Nordisk Investigational Site
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Stockholm, Sweden, 111 57
- Novo Nordisk Investigational Site
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St. Gallen, Switzerland, 9016
- Novo Nordisk Investigational Site
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Stevenage, United Kingdom, SG1 4AB
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This study will include adults with T2DM.
Collecting data reported in medical records of patients with T2DM who received their first prescription of Xultophy® at least 6 months prior to inclusion in this study, no matter whether Xultophy® was continued afterwards.
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Insulin degludec/liraglutide
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This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in HbA1c (Hemoglobin A1c)
Time Frame: week 0, week 26
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week 0, week 26
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change in HbA1c
Time Frame: Month 0, month 3, month 9, months 12
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Month 0, month 3, month 9, months 12
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Percentage of responders for HbA1c below 7 percent (53 mmol/mol)
Time Frame: At 3, 6, 9 and 12 months
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At 3, 6, 9 and 12 months
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Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain
Time Frame: At 3, 6, 9 and 12 months
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At 3, 6, 9 and 12 months
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Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes
Time Frame: At 3, 6, 9 and 12 months
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At 3, 6, 9 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2016
Primary Completion (Actual)
October 20, 2016
Study Completion (Actual)
October 20, 2016
Study Registration Dates
First Submitted
April 27, 2016
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9068-4264
- U1111-1176-6538 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.