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

Novo Nordisk A/S662 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

662

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

Insulin degludecDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (32)

Outcomes

Primary Outcomes

Change in Glycated Haemoglobin (HbA1c)

measured in % point

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

Secondary Outcomes

Change in percentage of patients with HbA1c below 7%

percentage of patients

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

Change in percentage of patients with HbA1c below 7.5%

percentage of patients

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

Change in percentage of patients with HbA1c below 8.0%

percentage of patients

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

Change in the mean Fasting Plasma Glucose (FPG)

measured in mmol/L

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

Insulin degludec dose

measured in units/day

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

Insulin degludec dose

measured in units/day

Time frame: 6 months after switch to insulin degludec

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

measured in units/day

Data from ClinicalTrials.gov

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