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ID
Source
Brief title
Health condition
Type 2 Diabetes Mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean change in HbA1c between baseline to study end (week 24)
Secondary outcome
* Mean change in PRO score from baseline to week 12 and from baseline to study end (week 24);
WHO-5 - emotional well-being (5 items)
IWQOL-LITE – Impact of weight on quality of life (5 domains, 31 items)
SDSCA – 1 item medication-adherence
DMSRQ – treatment satisfaction/convenience
* Mean change in HbA1c between baseline and week 12;
* The percentage of patients reaching HbA1c <7% after 24 weeks;
* Mean change in body weight and BMI between baseline and week 12 and week 24;
Background summary
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.
Study objective
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.
Study design
Baseline, week 12, week 24
Intervention
No therapeutic interventions. Patients are asked to complete PROs at three different time points (baseline, Month 3, Month 6).
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7648 |
| Other | MEC-U : NWMO19.04.016 |