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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24198
Enrollment
107
Registered
2019-04-02
Start date
2020-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

No therapeutic interventions. Patients are asked to complete PROs at three different time points (baseline, Month 3, Month 6).

Sponsors

Sanofi
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Mean change in HbA1c between baseline to study end (week 24)

Secondary

MeasureTime frame
* 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;

Contacts

Public ContactThera Max- Mos

Sanofi

startup.nl@sanofi.com+31 (0)20 245 4000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)