drugset / Trial / NCT02526810
Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
Phase 4
Unknown
70 enrolled
Third Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial Department of Science and Technology · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-07
- Primary completion
- 2016-08
- Completion
- 2016-09
Publications
- 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.5 iu/kg | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 0.2 iu/kg | — |
| Background | Gliclazide | Small molecule | 60 mg | Oral |
| Background | Metformin | Small molecule | 500 mg | Oral |