Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin lispro
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria). 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 Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%. agree to participate the study and sign the informed consent. Exclusion Criteria: obvious failure of heart, hepatic, kidney function. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug. women in pregnancy or planning to get pregnancy.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A<br>using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg. | Drug: insulin lispro<br>* continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level<br>* Other names: Humalog;|
| Experimental: GROUP B<br>using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd. | Drug: Insulin Glargine<br>* long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean 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. | 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin A1c | changes of HbA1c before and after the intervention | 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 | 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 | 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 | 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 | 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 | From date of randomization until the end of study, assessed up to 15 days | 
| insulin secretion-sensitivity index | changes of insulin secretion-sensitivity index before and after the intervention | 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 | From date of randomization until the end of study, assessed up to 15 days | 
| standard deviation of glucose level | standard deviation of glucose level | 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 | 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 | during three days' CGMS | 
| thiobarbituric acid reactive substance | changes of thiobarbituric acid reactive substance before and after the intervention | 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 | From date of randomization until the end of study, assessed up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glargine, continuous subcutaneous insulin injection, blood glucose control, blood glucose fluctuation, Oxidative Stress