PMID- 23698396
OWN - NLM
STAT- MEDLINE
DCOM- 20140423
LR  - 20220318
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 36
IP  - 10
DP  - 2013 Oct
TI  - Efficacy and safety of lixisenatide once daily versus exenatide twice daily in 
      type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, 
      open-label, active-controlled study (GetGoal-X).
PG  - 2945-51
LID - 10.2337/dc12-2709 [doi]
AB  - OBJECTIVE: To compare efficacy and safety of lixisenatide once daily versus 
      exenatide twice daily in type 2 diabetes inadequately controlled with metformin. 
      RESEARCH DESIGN AND METHODS: Adults with diabetes inadequately controlled (HbA1c 
      7-10%) with metformin were randomized to lixisenatide 20 mug once daily (n=318) or 
      exenatide 10 mug twice daily (n=316) in a 24-week (main period), open-label, 
      parallel-group, multicenter study. The primary objective was a noninferiority 
      assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 
      24. RESULTS: Lixisenatide once daily demonstrated noninferiority in HbA1c 
      reduction versus exenatide twice daily. The least squares mean change was -0.79% 
      (mean decrease 7.97 to 7.17%) for lixisenatide versus -0.96% (mean decrease 7.96 
      to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 
      0.033-0.297), meeting a predefined noninferiority upper CI margin of 0.4%. 
      Responder rate (HbA1c<7.0%) and improvements in fasting plasma glucose were 
      comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 
      to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse 
      events (AEs) was similar for lixisenatide and exenatide, as was incidence of 
      serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs 
      occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the 
      lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 
      vs. 7.9%; P<0.05), with fewer gastrointestinal events (especially nausea; 24.5 
      vs. 35.1%; P<0.05). CONCLUSIONS: Add-on lixisenatide once daily in type 2 
      diabetes inadequately controlled with metformin demonstrated noninferior 
      improvements in HbA1c, with slightly lower mean weight loss, lower incidence of 
      hypoglycemia, and better gastrointestinal tolerability compared with exenatide 
      twice daily.
FAU - Rosenstock, Julio
AU  - Rosenstock J
AD  - Corresponding author: Julio Rosenstock, juliorosenstock@dallasdiabetes.com.
FAU - Raccah, Denis
AU  - Raccah D
FAU - Koranyi, Laszlo
AU  - Koranyi L
FAU - Maffei, Laura
AU  - Maffei L
FAU - Boka, Gabor
AU  - Boka G
FAU - Miossec, Patrick
AU  - Miossec P
FAU - Gerich, John E
AU  - Gerich JE
LA  - eng
SI  - ClinicalTrials.gov/NCT00707031
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130522
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 74O62BB01U (lixisenatide)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/*therapeutic use
MH  - Male
MH  - Metformin/*administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Peptides/*administration & dosage/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3781502
EDAT- 2013/05/24 06:00
MHDA- 2014/04/24 06:00
PMCR- 2014/10/01
CRDT- 2013/05/24 06:00
PHST- 2013/05/24 06:00 [entrez]
PHST- 2013/05/24 06:00 [pubmed]
PHST- 2014/04/24 06:00 [medline]
PHST- 2014/10/01 00:00 [pmc-release]
AID - dc12-2709 [pii]
AID - 2709 [pii]
AID - 10.2337/dc12-2709 [doi]
PST - ppublish
SO  - Diabetes Care. 2013 Oct;36(10):2945-51. doi: 10.2337/dc12-2709. Epub 2013 May 22.