Based on evidence to date, we can assume glycemic and weight benefits from IGlar combined with short-acting GLP-1 RA lixisenatide in T2DM in suboptimal glycemic control, but real-world evidence is needed. Moreover, whether these benefits translate…
ID
Bron
Verkorte titel
Aandoening
Type 2 Diabetes Mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean change in HbA1c between baseline to study end (week 24)
Achtergrond van het onderzoek
To evaluate the effectiveness of IGlarLixi in improving glycemic control and to assess change in patient well-being (PRO) after switch to IGlarLixi in T2DM patients inadequately controlled with basal insulin + metformin ± SU. This objective is being studied in a real-world setting, where patients are observed for 24 weeks after having been switched from basal insuline to IGlarLixi.
Doel van het onderzoek
Based on evidence to date, we can assume glycemic and weight benefits from IGlar combined with short-acting GLP-1 RA lixisenatide in T2DM in suboptimal glycemic control, but real-world evidence is needed. Moreover, whether these benefits translate into improved patient-reported outcomes (PRO’s) has yet to be established. In this context patients’ expectations and perceived convenience, weight-related QoL, hypoglycemia concerns and gastrointestinal side-effects are of particular interest.
Onderzoeksopzet
Baseline, week 12, week 24
Onderzoeksproduct en/of interventie
No therapeutic interventions. Patients are asked to complete PROs at three different time points (baseline, Month 3, Month 6).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
* T2DM patients on basal insulin for at least 3 months + metformin ± sulfonylureas;
* For which the Investigator has decided to prescribe IGlarLixi independently from entry in the study (within 1 week of study entry);
* BMI ≥ 30 kg/m2
* ≥ 18 years of age
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
* Diagnosis for T1DM;
* Use of mealtime insulin or premix insulin within 6 months before switching to IGlarlixi;
* Current use of GLP-1 RA;
* Hypersensitivity to IGlarLixi or any of its components;
* Pregnant (or intention to become pregnant during the course of the registry) or breast-feeding woman;
* Incapability to fill in PRO questionnaires (at the discretion of the investigator)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7648 |
| Ander register | MEC-U : NWMO19.04.016 |