Zixuan Wang1, Dengcheng Xu2, Lanhui Huang1, Tiantian Zhang3, Junqiao Wang1, Qing Chen1, Lei Kong1, Xinli Zhou4. 1. Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong Clinical Medical Center of Endocrinology and Metabolism, Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong, China. 2. Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong Clinical Medical Center of Endocrinology and Metabolism, Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong, China; Department of Endocrinology, The People's Hospital of Rizhao, Rizhao, Shandong, China. 3. Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong Clinical Medical Center of Endocrinology and Metabolism, Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong, China; Department of Hematology, The First Affiliated Hospital, Chinese PLA General Hospital, Beijing, China. 4. Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Shandong Clinical Medical Center of Endocrinology and Metabolism, Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, 324 Jing 5 Road, Jinan, Shandong, China. Electronic address: zhouxinli0301@163.com.
Abstract
AIMS: To assess the effect of saxagliptin monotherapy on blood glucose and islet β-cell function in obese patients with newly diagnosed pre-diabetes and abnormal fat metabolism. METHODS: A 24-week, randomized controlled trial was conducted involving 25 obese subjects with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) (mean age 45years) to receive lifestyle intervention only (control group) or combined with saxagliptin 2.5mg or 5mg daily (S2.5 or S5 group), metformin 1500mg daily (Met group). Anthropometrics, body fat and biochemical parameters were measured before and after 4, 12 and 24weeks intervention. RESULTS: S5 group and Met group showed a significant decrease in fasting plasma glucose (FPG) and HbA1c compared with the control group (all P<0.05) after 24-week intervention. However, the decrease in 2h postprandial plasma glucose levels (2hPPG) in S5 group were greater compared with control group (P<0.01). Insulin resistance (HOMA-IR) was reduced in S5 group, Met group and control group (P<0.05), and the β-cell function (HOMA-β) was improved in all groups (P<0.05). However, the changes in obesity-related indicators including waist circumference, hip circumference, weight, BMI, body fat, percentage of body fat and waist-to-hip fat ratio were greate in Met group (all P<0.05) compared with other groups (P>0.05). CONCLUSIONS:Saxagliptin monotherapy may prevent or delay the progression of IGT or IFG to type 2 diabetes mellitus in obese patients with newly diagnosed pre-diabetes. ClinicalTrials.gov: NCT01960205.
RCT Entities:
AIMS: To assess the effect of saxagliptin monotherapy on blood glucose and islet β-cell function in obesepatients with newly diagnosed pre-diabetes and abnormal fat metabolism. METHODS: A 24-week, randomized controlled trial was conducted involving 25 obese subjects with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) (mean age 45years) to receive lifestyle intervention only (control group) or combined with saxagliptin 2.5mg or 5mg daily (S2.5 or S5 group), metformin 1500mg daily (Met group). Anthropometrics, body fat and biochemical parameters were measured before and after 4, 12 and 24weeks intervention. RESULTS: S5 group and Met group showed a significant decrease in fasting plasma glucose (FPG) and HbA1c compared with the control group (all P<0.05) after 24-week intervention. However, the decrease in 2h postprandial plasma glucose levels (2hPPG) in S5 group were greater compared with control group (P<0.01). Insulin resistance (HOMA-IR) was reduced in S5 group, Met group and control group (P<0.05), and the β-cell function (HOMA-β) was improved in all groups (P<0.05). However, the changes in obesity-related indicators including waist circumference, hip circumference, weight, BMI, body fat, percentage of body fat and waist-to-hip fat ratio were greate in Met group (all P<0.05) compared with other groups (P>0.05). CONCLUSIONS:Saxagliptin monotherapy may prevent or delay the progression of IGT or IFG to type 2 diabetes mellitus in obesepatients with newly diagnosed pre-diabetes. ClinicalTrials.gov: NCT01960205.