The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.
This study was a single-center, randomized, controled and prospective trial. Type 2 diabetic patients were randomized into 2 groups (Group A and Group B). Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al. The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Guangzhou, Guangdong, China
RECRUITINGmean amplitude of glycemic excursions( MAGE)
a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.
Time frame: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
glycated hemoglobin A1c
changes of HbA1c before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
glycated albumin
changes of glycated albumin before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
fasting plasma glucose, postprandial plasma glucose (30min, 120min)
changes of fasting and postprandial plasma glucose before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
Fasting C-peptide
changes of Fasting C-peptide before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
Fasting insulin
changes of Fasting insulin before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
Homa-β
changes of Homa-β before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
insulin secretion-sensitivity index
changes of insulin secretion-sensitivity index before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
disposition index
changes of disposition index before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
standard deviation of glucose level
standard deviation of glucose level
Time frame: during three days' CGMS
area under curve (AUC) when the glucose level was higher than 7.8mmol/L
AUC when the glucose level was higher than 7.8mmol/L
Time frame: during three days' CGMS
area under curve (AUC) when the glucose level was lower than 3.9mmol/L
AUC when the glucose level was higher than 3.9mmol/L
Time frame: during three days' CGMS
thiobarbituric acid reactive substance
changes of thiobarbituric acid reactive substance before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days
the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
changes of the level of blood 8-OHdG substance before and after the intervention
Time frame: From date of randomization until the end of study, assessed up to 15 days