GLPwatch
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.
Diabetes Care · 2016
Last updated 2026-05-28In a 30-week study of 736 people with type 2 diabetes already on basal insulin, those who switched to a once-daily combination of insulin glargine plus lixisenatide (iGlarLixi) saw their blood sugar control improve more than those who stayed on insulin glargine alone (-1.1% vs. -0.6% drop in HbA levels). About 55% of the combination group reached a target blood sugar level of less than 7.0%, compared to 30% in the insulin-only group. People in the combination group also lost an average of 0.7 kg, while those on insulin alone gained 0.7 kg. Both groups had similar rates of low blood sugar events.
AI summary of the abstract below.
| Journal | Diabetes Care, 2016 |
|---|---|
| Citations | 219 |
| Relative citation ratio | 8.17 |
| NIH percentile | 97 |
| Molecules | lixisenatide |
| Conditions studied | Type 2 Diabetes |
Abstract
OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.
RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA levels at 30 weeks.
RESULTS: HbA decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.
CONCLUSIONS: Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.
Verbatim abstract via PubMed 27650977 ↗
Related research
- Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.
- Drugs developed to treat diabetes, liraglutide and lixisenatide, cross the blood brain barrier and enhance neurogenesis.
- Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L).
- Trial of Lixisenatide in Early Parkinson's Disease.
- Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia).
- Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).
- Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial.
- Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial.