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Lix5.0
Lixisenatide Research
Mostly mechanism / observationalLimited safety
11 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Lixisenatide studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2012–2019 with a typical study size of 495 participants.
Based on 11 studies · 6 meta-analyses · 5 RCTs · 8,042 total participants
Confidence
High
By outcome
Blood sugar & glycemic control
Mostly mechanism / observational11 studies
Safety & adverse effects
Mostly mechanism / observational10 studies
Weight management
Mostly mechanism / observational5 studies
Cardiovascular outcomes
Mostly mechanism / observational3 studies
Older research base
Newest study from 2019 · Latest meta-analysis: 2019
20122019
1Meta-Analysis2019
Overall, GLP-1 receptor agonist treatment reduced MACE by 12% (HR 0.88, 95% CI 0.82-0.94; p<0.0001)... a broad composite kidney outcome by 17% (0.83, 0.78-0.89; p<0.0001)... There was no increase in risk of severe hypoglycaemia, pancreatitis, or pancreatic cancer.
Class-level 12% reduction in MACE (HR 0.88, 95% CI 0.82-0.94), with 12% lower cardiovascular and all-cause mortality and 9% fewer heart-failure hospitalizations
17% reduction in a composite kidney outcome (HR 0.83), mainly driven by reduced urinary albumin excretion
A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81).
Cardiovascular-outcomes RCT: 6,068 patients with type 2 diabetes and a recent acute coronary syndrome (MI or unstable angina within 180 days), lixisenatide vs placebo added to usual care, median 25 months
Primary MACE composite NEUTRAL — non-inferior but NOT superior to placebo (HR 1.02; 95% CI 0.89-1.17); no cardiovascular benefit demonstrated
No difference in heart-failure hospitalization (HR 0.96) or death (HR 0.94)
Once-daily lixisenatide significantly improved HbA1c (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001).
Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. · Diabetes Care (2012)
Phase-3 double-blind 12-week RCT, 361 drug-naive patients with type 2 diabetes randomized to lixisenatide (two titration regimens) or placebo
Modest but significant HbA1c reduction (LS mean -0.54% to -0.66% vs placebo)
Pronounced postprandial effect — 75% reduction in glucose excursion during a standardized breakfast test
With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%.
Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. · Diabetes Care (2013)
Phase-3 double-blind RCT, 495 patients on established basal insulin with inadequate control, add-on lixisenatide 20 µg vs placebo for 24 weeks
Modest placebo-corrected HbA1c reduction of -0.4%; more patients reached HbA1c <7% (28% vs 12%)
Strong postprandial glucose reduction (-3.8 mmol/L after standardized breakfast) and modest weight loss (-1.3 kg) with a small insulin-dose reduction
After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%).
Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. · Diabetes Obes Metab (2013)
Phase-3 double-blind RCT, 484 patients insufficiently controlled on pioglitazone ± metformin, lixisenatide 20 µg vs placebo for 24 weeks (+ extension)
Significant but modest HbA1c improvement (-0.56% vs placebo) and improved fasting plasma glucose
Only a small decrease in body weight (no significant difference vs placebo)
A significant reduction in HbA1c at 76 weeks was observed in the intervention arm compared to placebo (LSM difference: -0.41%, 95%CI: -0.51, -0.32, P < .00001)... A bodyweight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, P = .05).
Broglio F, Mannucci E, Napoli R, Nicolucci A, Purrello F, Nikonova E, Stager W, Trevisan R. · Diabetes Obes Metab (2017)
Meta-analysis of 76-week results from 5 placebo-controlled GetGoal trials (~3,000 patients) as add-on to various background therapies
Long-term HbA1c reduction modest (-0.41%) and durable; larger decreases in fasting glucose and postprandial excursion
Body-weight reduction was small (-0.40 kg) — confirms lixisenatide is not a meaningful weight-loss agent
Lixisenatide significantly reduced 2-h PPG from baseline (LS mean difference vs. placebo: -4.9 mmol/l, p < 0.001) and glucose excursion (LS mean difference vs. placebo: -4.5 mmol/l, p < 0.001).
Lixisenatide plus basal insulin was significantly more effective than basal insulin alone at reducing HbA1c at 24 weeks... Lixisenatide plus basal insulin was associated with an increased incidence of hypoglycemia versus basal insulin alone.
Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. · J Diabetes Complications (2014)
Meta-analysis pooling 3 GetGoal trials of lixisenatide vs placebo added to basal insulin (± oral agents)
Significant improvement in HbA1c and especially postprandial glucose vs basal insulin alone
Complementary mechanism: lixisenatide controls PPG while basal insulin controls FPG