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Completed

NCT Number: NCT03674866

A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus

The purpose of this study is to collect historical data in real life conditions in a large group of people who have type 1 or type 2 diabetes and were treated with Tresiba® (insulin degludec) for at least 6 months. Data will be collected beginning 6 months before the participant started Tresiba® up to around 6 months after the participant started taking insulin degludec.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases 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, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient
  • Male or female age greater than or equal to 18 years at the time of insulin degludec initiation
  • Type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus patients
  • Switched to insulin degludec (± prandial insulin) after any basal insulin (± prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with insulin degludec at the time of patient selection
  • Previously treated with any basal insulin (± prandial insulin) for at least 6 months prior to switching to insulin degludec
  • At least one documented medical visit in the first 6 months (closest value in 3 to 9 months window) after insulin degludec initiation
  • Minimum available data at the time of insulin degludec initiation: age, type of diabetes, HbA1c, duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site for at least 1 year, and an estimated glomerular filtration rate (eGFR) value in the last 12 ±6 months (full data period)

Exclusion criteria

  • Previous participation in this study. Participation is defined as having signed the Informed Consent in this study
  • Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba

Treatment and study plan

insulin degludec

Drug

Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    measured in % point

Secondary outcomes

  1. Change in percentage of patients with HbA1c below 7%

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    percentage of patients

  2. Change in percentage of patients with HbA1c below 7.5%

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    percentage of patients

  3. Change in percentage of patients with HbA1c below 8.0%

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    percentage of patients

  4. Change in the mean Fasting Plasma Glucose (FPG)

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    measured in mmol/L

  5. Insulin degludec dose

    Time frame: At switch to insulin degludec (week 0)

    measured in units/day

  6. Insulin degludec dose

    Time frame: 6 months after switch to insulin degludec

    measured in units/day

  7. Change in the mean daily insulin doses (total, basal, prandial)

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    measured in units/day

  8. Change in the number of concomitant non-insulin glucose-lowering drug classes

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    number of concomitant non-insulin glucose-lowering drug classes

  9. Change in body weight

    Time frame: Baseline (up to 3 months prior to switch), 6 months after switch to insulin degludec

    measured in kg

  10. Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)

    Time frame: Before change to insulin degludec (-6 to 0 months)

    percentage of patients

  11. Change in the percentage of patients with at least one hypoglycaemic episode (overall, nonsevere,non-severe)

    Time frame: After change to insulin degludec (0 to 6 months)

    percentage of patients

  12. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)

    Time frame: Before change to insulin degludec (-6 to 0 months)

    rates of hypoglycaemic episodes

  13. Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal)

    Time frame: After change to insulin degludec (0 to 6 months)

    rates of hypoglycaemic episodes

  14. Percentage of patients continuing insulin degludec

    Time frame: After change to insulin degludec (0 to 6 months)

    percentage of patients

  15. Reason(s) for starting insulin degludec

    Time frame: At time of switch to insulin degludec (week 0)

    Reasons for starting insulin degludec (if available) will be classified as: Not at glycaemic target, Hypoglycaemia (severe / non-severe / nocturnal), Hypoglycaemia unawareness, Multiple risk factors for hypoglycaemia (elderly, intensive exercise, Chronic Kidney Disease, other), Basal insulin dose more than 80 units/day, Twice daily basal insulin dosing, Fasting blood glucose variability, Need for flexible time of dosing, Device issue, other

  16. Reason(s) for discontinuing insulin degludec

    Time frame: At time of discontinuing insulin degludec (0 to 6 months)

    Reasons for discontinuing insulin degludec (if applicable and available) will be classified as: Injection site reaction, Insufficient efficacy, Hypoglycaemia (severe / non-severe / nocturnal), Weight gain, Cost, Device issue, Other

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Canadian Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus CAN-TREAT (CANadian TREsiba AudiT)

Acronym: CAN-TREAT

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Dec 6, 2019

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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