A 6-month, multicenter, non-interventional Study to evaluate the Effectiveness and Quality of life impact of the Insulin glargine/Lixisenatide fixed ratio combination in patients with type 2 diabetes mellitus uncontrolled with basal insulin + metformin ± SU: an observational study
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NL-OMON24198
- Lead Sponsor
- Sanofi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 107
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)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c between baseline to study end (week 24)
- Secondary Outcome Measures
Name Time Method * Mean change in PRO score from baseline to week 12 and from baseline to study end (week 24);<br>? WHO-5 - emotional well-being (5 items)<br>? IWQOL-LITE – Impact of weight on quality of life (5 domains, 31 items)<br>? SDSCA – 1 item medication-adherence<br>? DMSRQ – treatment satisfaction/convenience<br>* Mean change in HbA1c between baseline and week 12;<br>* The percentage of patients reaching HbA1c <7% after 24 weeks;<br>* Mean change in body weight and BMI between baseline and week 12 and week 24;