PMID- 23628617
OWN - NLM
STAT- MEDLINE
DCOM- 20140421
LR  - 20220330
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 36
IP  - 9
DP  - 2013 Sep
TI  - Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by 
      established basal insulin: a 24-week, randomized, placebo-controlled comparison 
      (GetGoal-L).
PG  - 2489-96
LID - 10.2337/dc12-2454 [doi]
AB  - OBJECTIVE: To examine the efficacy and safety of adding the once-daily 
      glucagon-like peptide-1 receptor agonist (GLP-1RA) lixisenatide to established 
      basal insulin therapy alone or together with metformin, in people with type 2 
      diabetes and elevated glycated hemoglobin (HbA1c). RESEARCH DESIGN AND METHODS: 
      We conducted a double-blind, parallel-group, placebo-controlled trial. Patients 
      (n = 495) with established basal insulin therapy but inadequate glycemic control 
      were randomized to add lixisenatide 20 mug or placebo for 24 weeks. Basal insulin 
      dosage was unchanged except to limit hypoglycemia. HbA1c reduction from baseline 
      was the primary end point. RESULTS: Mean duration of diabetes was 12.5 years, 
      duration of insulin use was 3.1 years, insulin dosage was 55 units/day, and 
      baseline HbA1c was 8.4%. 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%. HbA1c <7.0% (53 mmol/mol) was attained by more lixisenatide (28%) 
      than placebo (12%; P < 0.0001) participants. Lixisenatide reduced plasma glucose 
      levels after a standardized breakfast (placebo-corrected reduction, -3.8 mmol/L; 
      P < 0.0001); seven-point glucose profiles showed a reduction persisting through 
      the day. Reductions in body weight (placebo corrected, -1.3 kg; P < 0.0001) and 
      insulin dosage (-3.7 units/day; P = 0.012) were greater with lixisenatide. Main 
      adverse events (AEs) with lixisenatide were gastrointestinal. Symptomatic 
      hypoglycemia was 28% for lixisenatide and 22% for placebo; 4 of 328 subjects 
      (1.2%) had severe hypoglycemia with lixisenatide vs. 0 of 167 with placebo. 
      CONCLUSIONS: By improving HbA1c and postprandial hyperglycemia without weight 
      gain in type 2 diabetes with inadequate glycemic control despite stable basal 
      insulin, lixisenatide may provide an alternative to rapid-acting insulin or other 
      treatment options.
FAU - Riddle, Matthew C
AU  - Riddle MC
AD  - Oregon Health & Science University, Portland, Oregon, USA. riddlem@ohsu.edu
FAU - Aronson, Ronnie
AU  - Aronson R
FAU - Home, Philip
AU  - Home P
FAU - Marre, Michel
AU  - Marre M
FAU - Niemoeller, Elisabeth
AU  - Niemoeller E
FAU - Miossec, Patrick
AU  - Miossec P
FAU - Ping, Lin
AU  - Ping L
FAU - Ye, Jenny
AU  - Ye J
FAU - Rosenstock, Julio
AU  - Rosenstock J
LA  - eng
SI  - ClinicalTrials.gov/NCT00975286
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130429
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Peptides)
RN  - 74O62BB01U (lixisenatide)
SB  - IM
MH  - Aged
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/*therapeutic use
MH  - Insulin/*administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Peptides/*administration & dosage/*therapeutic use
PMC - PMC3747925
EDAT- 2013/05/01 06:00
MHDA- 2014/04/22 06:00
PMCR- 2014/09/01
CRDT- 2013/05/01 06:00
PHST- 2013/05/01 06:00 [entrez]
PHST- 2013/05/01 06:00 [pubmed]
PHST- 2014/04/22 06:00 [medline]
PHST- 2014/09/01 00:00 [pmc-release]
AID - dc12-2454 [pii]
AID - 2454 [pii]
AID - 10.2337/dc12-2454 [doi]
PST - ppublish
SO  - Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.