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Effectiveness and safety of iGlarLixi in people with type 2 diabetes not at target on basal insulin and oral antidiabetic therapy in a prospective observational trial.
Diabetes Obes Metab · 2025
Last updated 2026-05-28In a 24-week study of 70 people with type 2 diabetes whose blood sugar control was not at target, switching to the combination drug iGlarLixi (insulin glargine plus lixisenatide) reduced their average blood sugar levels (HbA1c) by 0.74 percentage points, from 8.52% to 7.74%. Participants also saw their fasting blood sugar drop by about 33 mg/dL, lost an average of 3 kg, and spent more time within their target blood sugar range without an increase in low blood sugar events.
AI summary of the abstract below.
| Journal | Diabetes Obes Metab, 2025 |
|---|---|
| Citations | 2 |
| Molecules | — |
| Conditions studied | Type 2 Diabetes |
Abstract
AIMS: This study assessed efficacy and safety of the fixed ratio combination iGlarLixi 100/33 (insulin glargine 100 U/mL plus lixisenatide 33 μg/mL) in people with type 2 diabetes (PwT2D) in daily clinical practice.
MATERIALS AND METHODS: This non-interventional, multicentre, prospective, single-arm 24-week study documented PwT2D with an HbA1c of 7.5%-10.0%, currently treated with a basal insulin supported oral therapy (BOT) in German primary care facilities, after the physician had decided to change treatment to iGlarLixi 100/33, independent of study participation. Primary end-point was the absolute change in HbA1c (%) from baseline.
RESULTS: Of 93 participants included, 70 comprised the full analysis set for efficacy assessment. Approximately 24 weeks after switching to iGlarLixi 100/33 HbA1c (mean ± standard deviation) changed from 8.52 ± 0.82% by -0.74 ± 0.81% to 7.74 ± 0.76%, FPG from 174.3 ± 44.6 mg/dL (9.67 ± 2.48 mmol/L) by -32.9 ± 46.3 mg/dL (-1.83 ± 2.57 mmol/L) to 141.4 ± 34.1 mg/dL (7.85 ± 1.89 mmol/L) and body weight from 104.3 ± 22.5 kg by -3.0 ± 7.5 kg to 101.3 ± 21.6 kg (all p < 0.01). Furthermore, use of DPP4 inhibitors was significantly reduced from 34.8% to 6.8% of participants. Derived (from 7-point self-measured plasma glucose) time in range (TIR) increased and time above range (TAR) decreased after 24 weeks to target ranges (all p < 0.05). Flash glucose monitoring data of 20 patients showed similar patterns for TIR and TAR, respectively, and a reduction in time below range (p = 0.007). Hypoglycaemia events did not change significantly and were low in number. No severe hypoglycaemia was reported.
CONCLUSIONS: Modifying antiglycaemic treatment from a BOT regimen to iGlarLixi 100/33 in suboptimal controlled PwT2D in daily clinical practice improved glycaemic control without increasing hypoglycaemia and with favourable body weight change.
Verbatim abstract via PubMed 39757952 ↗