Lixisenatide treatment for older patients with type 2 diabetes mellitus uncontrolled on oral antidiabetics: meta-analysis of five randomized controlled trials

Adv Ther. 2014 Aug;31(8):861-72. doi: 10.1007/s12325-014-0146-4. Epub 2014 Aug 21.


Aim: Evaluate the efficacy and safety of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in older patients with type 2 diabetes mellitus (T2DM) insufficiently controlled on oral antidiabetics (OADs).

Methods: A meta-analysis was conducted on data from older patients (≥65 years) from five of the GetGoal trials, in which patients with T2DM were treated with lixisenatide 20 µg once daily or placebo, as an add-on to OADs. The primary endpoint in all trials was change from baseline at week 24 in glycated hemoglobin (HbA1c). Other endpoints included changes in post-prandial plasma glucose (PPG), fasting plasma glucose (FPG) and weight. Composite and safety endpoints were also analyzed.

Results: A total of 501 patients aged ≥65 years were included in this meta-analysis: 304 received lixisenatide plus OADs and 197 received placebo as add-on to OADs. Lixisenatide as an add-on to OADs significantly reduced HbA1c, PPG, FPG and weight, with placebo-corrected treatment effects at week 24 of -0.54% (p<0.0001), -126 mg/dL (p<0.0001), -13 mg/dL (p=0.0005) and -0.90 kg (p=0.0021), respectively. Patients receiving lixisenatide plus OADs were significantly more likely to achieve composite (HbA1c levels<7%, HbA1c levels<7% and no symptomatic hypoglycemia, and HbA1c levels<7%, no weight gain and no symptomatic hypoglycemia) and safety endpoints than those receiving placebo plus OADs. Symptomatic hypoglycemia was experienced by 8.55% and 3.55% of patients in the lixisenatide plus OADs and placebo plus OADs groups, respectively (p=0.0276), although no serious hypoglycemic episodes were reported.

Conclusions: Lixisenatide plus OADs improved glycemic control in older patients inadequately controlled on OADs compared with placebo plus OADs. Lixisenatide is well tailored to the pathophysiology of T2DM in older patients.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Glucose
  • Body Weight
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Glycated Hemoglobin A / analysis
  • Humans
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Peptides / administration & dosage
  • Peptides / adverse effects
  • Peptides / therapeutic use*
  • Postprandial Period
  • Randomized Controlled Trials as Topic


  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Peptides
  • lixisenatide