Diabetes Mellitus, Type 2 Clinical Trial
— EU-TREATOfficial title:
A European 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
Verified date | April 2019 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 2302 |
Est. completion date | August 12, 2016 |
Est. primary completion date | August 12, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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® |
Country | Name | City | State |
---|---|---|---|
Austria | Novo Nordisk Investigational Site | Wien | |
Austria | Novo Nordisk Investigational Site | Wien | |
Denmark | Novo Nordisk Investigational Site | Gentofte | |
Germany | Novo Nordisk Investigational Site | München | |
Greece | Novo Nordisk Investigational Site | Athens | |
Italy | Novo Nordisk Investigational Site | Perugia | |
Switzerland | Novo Nordisk Investigational Site | St. Gallen |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Austria, Denmark, Germany, Greece, Italy, Switzerland,
Siegmund T, Tentolouris N, Knudsen ST, Lapolla A, Prager R, Phan TM, Wolden ML, Schultes B; EU-TREAT study group. A European, multicentre, retrospective, non-interventional study (EU-TREAT) of the effectiveness of insulin degludec after switching basal in — View Citation
Tentolouris N, Knudsen ST, Lapolla A, Wolden ML, Haldrup S, Schultes B. Switching "Real-World" Diabetes Patients to Degludec from Other Basal Insulins Provides Different Clinical Benefits According to Their Baseline Glycemic Control. Adv Ther. 2019 May;36 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in HbA1c after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | 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 6 | ||
Secondary | 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 | ||
Secondary | Change in the mean FPG (Fasting Plasma Glucose ) level after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in the mean FPG level after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | Tresiba® starting dose at switch and doses | At 6 months | ||
Secondary | Tresiba® starting dose at switch and doses | At 12 months | ||
Secondary | Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in the mean daily insulin doses (total, basal, prandial) after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in the number of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | Change in mean dose of concomitant non-insulin glucose-lowering drug classes after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | Change in body weight (kg) after switch to Tresiba® | Month 0, Month 6 | ||
Secondary | Change in body weight (kg) after switch to Tresiba® | Month 0, Month 12 | ||
Secondary | Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® | ||
Secondary | 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 +6 months | ||
Secondary | Change in the percentage of patients with at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® | ||
Secondary | 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 | ||
Secondary | Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | -6 to 0 months ie 6 months before switch to Tresiba® | ||
Secondary | Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | 0 to +6 months | ||
Secondary | Change in the rates of hypoglycaemic episodes (overall, non-severe, severe, nocturnal) before and after switch to Tresiba® (per patient-month) | -12 to 0 months ie 12 months before switch to Tresiba® | ||
Secondary | 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 | ||
Secondary | 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® | ||
Secondary | Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months | ||
Secondary | Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® | ||
Secondary | Change in the number of ER visits related to hypoglycaemia after switch to Tresiba® | 0 to +12 months | ||
Secondary | 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®) | ||
Secondary | Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | 0 to +6 months | ||
Secondary | Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® | ||
Secondary | Change in the number of HCP visits related to hypoglycaemia after switch to Tresiba® | 0 to +12 months | ||
Secondary | Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | -6 to 0 months ie 6 months before switch to Tresiba® | ||
Secondary | Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | 0 to +6 months | ||
Secondary | Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | -12 to 0 months ie 12 months before switch to Tresiba® | ||
Secondary | Change in the number of hospitalisations related to hypoglycaemia after switch to Tresiba® | 0 to +12 months | ||
Secondary | Percentage of patients continuing Tresiba® post-switch | At 6 months | ||
Secondary | Percentage of patients continuing Tresiba® post-switch | At 12 months | ||
Secondary | Reason(s) for starting Tresiba®, if available | Month 0, Month 12 | ||
Secondary | Reason(s) for discontinuing Tresiba®, if applicable and available | Month 0, Month 12 |
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