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NCT Number: NCT02754817

A 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec/liraglutide

Drug

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.

Primary outcomes

  1. Change in HbA1c (Hemoglobin A1c)

    Time frame: week 0, week 26

Secondary outcomes

  1. Change in HbA1c

    Time frame: Month 0, month 3, month 9, months 12

  2. Percentage of responders for HbA1c below 7 percent (53 mmol/mol)

    Time frame: At 3, 6, 9 and 12 months

  3. Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain

    Time frame: At 3, 6, 9 and 12 months

  4. Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes

    Time frame: At 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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