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| Name | Class |
|---|---|
| Guangdong Provincial Department of Science and Technology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Active Comparator | using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg. |
|
| GROUP B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin lispro | Drug | continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of hypoglycemia | the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L | From date of randomization until the end of study, assessed up to 15 days |
| the incidence of severe hypoglycemia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeng Longyi, professor | Contact | 0086-020-85252160 | zssynfmk@163.com | |
| Lin Shuo, doctor | Contact | 0086-020-85253408 | littltpig@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Zeng Longyi, professor | Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20335585 | Background | Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292. | |
| 18502299 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Glargine | Drug | long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level |
|
|
| 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 |
defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L
| From date of randomization until the end of study, assessed up to 15 days |
| Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X. |
| 21898754 | Background | Mu PW, Chen YM, Lu HY, Wen XQ, Zhang YH, Xie RY, Shu J, Wang MM, Zeng LY. Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes. Diabetes Metab Res Rev. 2012 Mar;28(3):236-40. doi: 10.1002/dmrr.1292. |
| 21877913 | Background | Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-cell function improvement in newly diagnosed type 2 diabetes patients: basal insulin monotherapy versus continuous subcutaneous insulin infusion treatment. Diabetes Technol Ther. 2012 Jan;14(1):35-42. doi: 10.1089/dia.2011.0123. Epub 2011 Aug 30. |
| 11522721 | Background | Brun E, Zoppini G, Zamboni C, Bonora E, Muggeo M. Glucose instability is associated with a high level of circulating p-selectin. Diabetes Care. 2001 Sep;24(9):1685. doi: 10.2337/diacare.24.9.1685. No abstract available. |
| 10857967 | Background | Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. doi: 10.2337/diacare.23.1.45. |
| 24998009 | Background | Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2. |
| 10645822 | Background | Hanson RL, Pratley RE, Bogardus C, Narayan KM, Roumain JM, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC. Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemiologic studies. Am J Epidemiol. 2000 Jan 15;151(2):190-8. doi: 10.1093/oxfordjournals.aje.a010187. |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |