Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Site and patient selection:
This non-interventional study (NIS) was conducted in accordance with Good Pharmacoepidemiology Practice (GPP) guidelines and in accordance with local legal and ethical guid
Sponsors
Sanofi (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with type 2 diabetes mellitus 2. In treatment with OADs and a basal insulin without predialysis insulin and without GLP1-RA for at least 6 months 3. HbA1c 7.5% to 10.0% (findings from the last 3 months) 4. Presence of prior basal insulin therapy that is stable between 30-60 units per day 5. Switching to iGlarLixi takes place between 14 days before the initial documentation and 7 days after the initial documentation 6. Decision of the treating physician to replace the previous basal insulin with iGlarLixi regardless of the enrolment in the study 7. Ability and willingness to perform 7-point glucose daily profile measurements using a glucometer OR self-management using an FGM system. FGM patients should only be included if: 7.1. At least 70% of recorded sensor data from the FGM daily profiles of the last approx. 14 days (max. 3 weeks) are available before switching to iGlarLixi 7.2. No change of the FGM system manufacturer used during the study period is planned; however, a switch to a device of the same manufacturer (e.g. the latest device generation) is possible 7.3. Calibration of the FGM system is guaranteed according to the manufacturer’s specifications 8. Informed consent signed by the patient and physician
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus 2. Contraindications to treatment with iGlarLixi according to the Summary of Product Characteristics 3. Participation in clinical research 4. Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study 5. Daily basal insulin dose 60 units
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of the absolute change in HbA1c (%) from switching to iGlarLixi (fixed ratio combination [FRC] of insulin glargine 100 U/mL and 33 µg/mL lixisenatide) treatment from an existing BOT in everyday clinical practice until approx. 12 and approx. 24 weeks, respectively, after start of iGlarLixi treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of the changes in other glycaemic parameters, during approx. 12 and approx. 24 weeks of treatment with iGlarLixi, respectively, and documentation of the tolerability of iGlarLixi in everyday clinical practice. The following secondary endpoints were evaluated: 1. Relative change in HbA1c (%) 2. Absolute and relative change in self-measured fasting blood glucose (FBG) (mg/dL) 3. Proportion of patients achieving their individualised HbA1c target (%) 4. Proportion of patients achieving FBG =110 mg/dL [=6.1 mmol/L] (%) 5. Absolute and relative change in 7-point blood glucose daily profile (mg/dL) 6. Last dose of previous basal insulin (units/day [U/d]) 7. Absolute and relative change in iGlarLixi dose (dose steps/day [DS/d]) 8. Absolute and relative change in body weight (kg) 9. Absolute change in BMI (kg/m²) 10. Absolute and relative change in glucose measured at median (mg/dL) 11. Absolute and relative change in SD of glucose profiles (mg/dL) 12. Incidence and rate of hypoglycaemic episodes3 (documented hypoglycaemic episodes within the last approx. 12 weeks prior to study inclusion compared to the last 12 weeks prior to documentation 2 [after approx. 12 weeks] and the last 12 weeks prior to the final documentation [after approx. 24 weeks]) 13. Change in treatment satisfaction using DTSQs and DTSQc | — |
Countries
Germany
Contacts
Public ContactKatrin Pegelow
Outcome results
None listed