期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 387, 期 12, 页码 1063-1074出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2200433
关键词
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资金
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH)
- U34 planning grant [U01DK098246]
- American Diabetes Association [U34-DK-088043]
- National Heart, Lung, and Blood Institute
- Centers for Disease Control and Prevention
- NIH
- [P30 DK017047]
- [P30 DK020541-44]
- [P30 DK020572]
- [P30 DK072476]
- [P30 DK079626]
- [P30 DK092926]
- [U54 GM104940]
- [UL1 TR000170]
- [UL1 TR000439]
- [UL1 TR000445]
- [UL1 TR001102]
- [UL1 TR001108]
- [UL1 TR001409]
- [2UL1TR001425]
- [UL1 TR001449]
- [UL1 TR002243]
- [UL1 TR002345]
- [UL1 TR002378]
- [UL1 TR002489]
- [UL1 TR002529]
- [UL1 TR002535]
- [UL1 TR002537]
- [UL1 TR002541]
- [UL1 TR002548]
In this trial, all four glucose-lowering medications added to metformin were effective in reducing glycated hemoglobin levels. Glargine and liraglutide showed modestly superior efficacy in achieving and maintaining target glycated hemoglobin levels.
Glycemic Outcomes of Glycemia ReductionIn a trial of the glucose-lowering medications glargine, glimepiride, liraglutide, and sitagliptin added to metformin to maintain target glycated hemoglobin levels, all four decreased these levels. BACKGROUND The comparative effectiveness of glucose-lowering medications for use with metformin to maintain target glycated hemoglobin levels in persons with type 2 diabetes is uncertain. METHODS In this trial involving participants with type 2 diabetes of less than 10 years' duration who were receiving metformin and had glycated hemoglobin levels of 6.8 to 8.5%, we compared the effectiveness of four commonly used glucose-lowering medications. We randomly assigned participants to receive insulin glargine U-100 (hereafter, glargine), the sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or sitagliptin, a dipeptidyl peptidase 4 inhibitor. The primary metabolic outcome was a glycated hemoglobin level, measured quarterly, of 7.0% or higher that was subsequently confirmed, and the secondary metabolic outcome was a confirmed glycated hemoglobin level greater than 7.5%. RESULTS A total of 5047 participants (19.8% Black and 18.6% Hispanic or Latinx) who had received metformin for type 2 diabetes were followed for a mean of 5.0 years. The cumulative incidence of a glycated hemoglobin level of 7.0% or higher (the primary metabolic outcome) differed significantly among the four groups (P < 0.001 for a global test of differences across groups); the rates with glargine (26.5 per 100 participant-years) and liraglutide (26.1) were similar and lower than those with glimepiride (30.4) and sitagliptin (38.1). The differences among the groups with respect to a glycated hemoglobin level greater than 7.5% (the secondary outcome) paralleled those of the primary outcome. There were no material differences with respect to the primary outcome across prespecified subgroups defined according to sex, age, or race or ethnic group; however, among participants with higher baseline glycated hemoglobin levels there appeared to be an even greater benefit with glargine, liraglutide, and glimepiride than with sitagliptin. Severe hypoglycemia was rare but significantly more frequent with glimepiride (in 2.2% of the participants) than with glargine (1.3%), liraglutide (1.0%), or sitagliptin (0.7%). Participants who received liraglutide reported more frequent gastrointestinal side effects and lost more weight than those in the other treatment groups. CONCLUSIONS All four medications, when added to metformin, decreased glycated hemoglobin levels. However, glargine and liraglutide were significantly, albeit modestly, more effective in achieving and maintaining target glycated hemoglobin levels. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; GRADE ClinicalTrials.gov number, .)
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