Diabetes Mellitus, Type 2
Conditions
Keywords
glargine, continuous subcutaneous insulin injection, blood glucose control, blood glucose fluctuation, Oxidative Stress
Brief summary
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.
Detailed description
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.
Interventions
DRUGinsulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
DRUGInsulin Glargine
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Sponsors
Guangdong Provincial Department of Science and Technology
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria). 2. diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years 3. Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%. 4. agree to participate the study and sign the informed consent.
Exclusion criteria
1. obvious failure of heart, hepatic, kidney function. 2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug. 3. women in pregnancy or planning to get pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean amplitude of glycemic excursions( MAGE) | 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days | a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glycated hemoglobin A1c | From date of randomization until the end of study, assessed up to 15 days | changes of HbA1c before and after the intervention |
| glycated albumin | From date of randomization until the end of study, assessed up to 15 days | changes of glycated albumin before and after the intervention |
| fasting plasma glucose, postprandial plasma glucose (30min, 120min) | From date of randomization until the end of study, assessed up to 15 days | changes of fasting and postprandial plasma glucose before and after the intervention |
| Fasting C-peptide | From date of randomization until the end of study, assessed up to 15 days | changes of Fasting C-peptide before and after the intervention |
| Fasting insulin | From date of randomization until the end of study, assessed up to 15 days | changes of Fasting insulin before and after the intervention |
| Homa-β | From date of randomization until the end of study, assessed up to 15 days | changes of Homa-β before and after the intervention |
| insulin secretion-sensitivity index | From date of randomization until the end of study, assessed up to 15 days | changes of insulin secretion-sensitivity index before and after the intervention |
| thiobarbituric acid reactive substance | From date of randomization until the end of study, assessed up to 15 days | changes of thiobarbituric acid reactive substance before and after the intervention |
| the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG) | From date of randomization until the end of study, assessed up to 15 days | changes of the level of blood 8-OHdG substance before and after the intervention |
| disposition index | From date of randomization until the end of study, assessed up to 15 days | changes of disposition index before and after the intervention |
| standard deviation of glucose level | during three days' CGMS | standard deviation of glucose level |
| area under curve (AUC) when the glucose level was higher than 7.8mmol/L | during three days' CGMS | AUC when the glucose level was higher than 7.8mmol/L |
| area under curve (AUC) when the glucose level was lower than 3.9mmol/L | during three days' CGMS | AUC when the glucose level was higher than 3.9mmol/L |
Other
| Measure | Time frame | Description |
|---|---|---|
| the incidence of hypoglycemia | From date of randomization until the end of study, assessed up to 15 days | the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L |
| the incidence of severe hypoglycemia | From date of randomization until the end of study, assessed up to 15 days | defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L |
Countries
China
Contacts
Primary ContactZeng Longyi, professor
Backup ContactLin Shuo, doctor
Outcome results
None listed