This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.
Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)\<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
5 μg BID for the first 4 weeks of treatment and 10 μg thereafter.
≥8 IU QD, and titrate based on a dosing algorithm targeting FPG \<6.1 mmol/L. Titration is only allowed in first 4 weeks.
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)
Time frame: 1±3day;112±3d
Glycemic variability
continuous overlapping net glycemic action (CONGA) and mean of daily differences (MODD)
Time frame: 1±3day;112±3d
Glucose control
Glycosylated hemoglobin A 1c (HbA1c), FBG, postprandial blood glucose (PBG)
Time frame: -7±3d;112±3d;
oxidative stress markers
plasma concentrations of superoxide dismutase (SOD), malondialdehyde, 8-iso-prostaglandin-F2α (8-iso-PGF2α) and urine concentrations of 8-iso-PGF2α;
Time frame: 1±3d;28±3d;56±3d;84±3d;112±3d
inflammatory markers
plasma concentrations of interleukin-1(IL-1), interleukin-18(IL-18), adiponectin, toll-like receptor 4(TLR-4) and phosphorylated-nuclear factor-kappaB 65 (pNF-κB 65) in white blood cells
Time frame: 1±3d;28±3d;56±3d;84±3d;112±3d
endothelial function
plasma total nitric oxide synthase (tNOS), inducible nitric oxide synthase (iNOS), nitric oxide (NO)
Time frame: 1±3d;28±3d;56±3d;84±3d;112±3d
beta-cell function and insulin resistance
homeostasis model assessment-β, homeostasis model assessment -insulin resistance, plasma glucagon, body mass index (BMI), waist-hip ratio
Time frame: 1±3d;112±3d;
body composition
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fat mass, lean tissue, body weight, waist circumference
Time frame: 1±3d;112±3d