HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P).

AbstractAIMS:
To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
METHODS:
This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24.
RESULTS:
In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. 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%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period.
CONCLUSIONS:
Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.
AuthorsM Pinget, R Goldenberg, E Niemoeller, I Muehlen-Bartmer, H Guo, R Aronson
JournalDiabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 15 Issue 11 Pg. 1000-7 (Nov 2013) ISSN: 1463-1326 [Electronic] England
PMID23627775 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Copyright© 2013 John Wiley & Sons Ltd.
Chemical References
  • GLP1R protein, human
  • Glucagon-Like Peptide-1 Receptor
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Peptides
  • Receptors, Glucagon
  • Thiazolidinediones
  • hemoglobin A1c protein, human
  • lixisenatide
  • Metformin
  • Pioglitazone
Topics
  • Aged
  • Diabetes Mellitus, Type 2 (blood, drug therapy)
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Monitoring
  • Drug Resistance
  • Drug Therapy, Combination (adverse effects)
  • Female
  • Glucagon-Like Peptide-1 Receptor
  • Glycated Hemoglobin (analysis)
  • Humans
  • Hyperglycemia (prevention & control)
  • Hypoglycemia (prevention & control)
  • Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
  • Intention to Treat Analysis
  • Male
  • Metformin (adverse effects, therapeutic use)
  • Middle Aged
  • Patient Dropouts
  • Peptides (administration & dosage, adverse effects, therapeutic use)
  • Pioglitazone
  • Receptors, Glucagon (agonists)
  • Thiazolidinediones (adverse effects, therapeutic use)
  • Weight Loss (drug effects)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: