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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Other: No treatment given

• Registration Number: NCT02662114
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effectiveness of Tresiba® (insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes mellitus.

EU-TREAT (EUropean TREsiba AudiT)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-04
• Study Start: 2015-12-08
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-25
• Primary Completion: 2016-08-12
• Study Completion: 2016-08-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2302

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
• Age at least 18 years at the time of Tresiba® initiation
• T1DM or insulin-treated T2DM patients
• Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection
• Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba®
• At least one documented medical visit in the first 9 months after Tresiba® initiation
• Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months

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Exclusion Criteria

• Previous participation in this study. Participation is defined as having signed the Informed Consent
• Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba®
• Current participation in another non-interventional study on insulin degludec (Tresiba®)
• Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tresiba®	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c after switch to Tresiba®	Month 0, Month 6

Secondary Outcome Measures

Name	Time	Method
Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba®	0 to +12 months
Change in the percentage of patients with HbA1c below recommended targets (below 7.0%, 7.5%, and 8.0%) after switch to Tresiba®	Month 0, Month 12
Change in the mean FPG level after switch to Tresiba®	Month 0, Month 12
Tresiba® starting dose at switch and doses	At 12 months
Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®	Month 0, Month 12
Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba®	Month 0, Month 6
Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba®	0 to +12 months
Change in HbA1c after switch to Tresiba®	Month 0, Month 12
Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba®	0 to +12 months
Change in the number of HCP (Healthcare professional(s)) visits related to hypoglycaemia after switch to Tresiba®	-6 to 0 months (ie 6 months before switch to Tresiba®)
Reason(s) for discontinuing Tresiba®, if applicable and available	Month 0, Month 12
Percentage of patients continuing Tresiba® post-switch	At 12 months
Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba®	Month 0, Month 12
Change in body weight (kg) after switch to Tresiba®	Month 0, Month 12
Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month)	0 to +12 months
Change in the number of ER (Emergency Room) visits related to hypoglycaemia after switch to Tresiba®	-6 to 0 months ie 6 months before switch to Tresiba®
Change in the number of ER visits related to hypoglycaemia after switch to Tresiba®	0 to +12 months
Reason(s) for starting Tresiba®, if available	Month 0, Month 12
Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba®	Month 0, Month 12

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 St. Gallen, Switzerland