Microalbuminuria Clinical Trial
Official title:
The Effects of Saxagliptin 5mg, Once Daily for 52 Weeks on 24 Hour Urine Albumin Creatinine Rate(ACR) , in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin or/and Acarbose
This study compare the effects on microalbuminuria improvement in type 2 diabetes mellitus (T2DM) treated with saxagliptin or glimepiride.All patients received metformin and/or acarbose, and randomly receive saxagliptin (5mg/d) or glimepiride (1-4mg/d).
Both sitagliptin and glimepiride are hypoglycemic agents,but they do so by different
mechanisms.sitagliptin can delay degradation of glucagon-like peptide -1 (GLP-1) by inhibit
DPPIV to decrease serum glucose level.glimepiride stimulates islets B cell to secrete
insulin to decrease serum glucose level.
Preclinical studies and several clinical trials (including vildagliptin, sitagliptin,
linagliptin, exenatide) suggested that DPP-4i/GLP-1 might have a potential to lower
albuminuria, albumin-creatinine ratio (ACR) or improve glomerular filtration rate(GFR) and
the effect might be independent of changes in glucose control. Recently, SAVOR outcomes also
showed that saxagliptin might have nephroprotective effects, and the proportion of patients
with microalbuminuria converted into normal albuminuria after saxagliptin treatment for 1
year is 31.3%, but the mechanism is still unclear.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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