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 (CAN-TREAT)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin degludec

Study type: Observational

Funder types: Industry

Identifiers

NCT03674866

U1111-1203-7872 (Other Identifier)

NN1250-4396

Details and patient eligibility

About

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.

Enrollment: 662 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

662 participants in 1 patient group

Patients with diabetes

Description:

Patients with type 1 diabetes and type 2 diabetes who received at least one prescription of insulin degludec (Tresiba®).

Treatment:

Drug: Insulin degludec