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In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin is getting paid more and more attention. A lot of studies have confirmed that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection. Based on these theory and practice, this study is designed to demonstrate whether the combination therapy of Gliclazide MR and basal insulin can control the blood glycemia effectively and reduce the dosage of insulin and the hypoglycemia events compared to the premix insulin monotherapy.
Inclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy | Experimental | The subjects allocated into this arm will receive the combination therapy of oral administration of 60~120mg Gliclazide MR (Diamicron MR) and subcutaneous injection of basal insulin (Insulin Glargine Injection, Lantus) once daily for 3 months |
|
| monotherapy | Active Comparator | The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gliclazide MR and Insulin Glargine Injection | Drug | Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| MBG, SDBG, MAGE and MODD in the 48th CGMS | 3 months | |
| Incidence of hypoglycemia and severe hypoglycemia | 3 months | |
| Weight change |
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Inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Jian Zhou, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Study Director |
| Yuqian Bao, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Study Director |
| Huazhang Yang, MD, PHD | Guangdong Provincial People's Hospital | Study Director |
| Jian Kuang, MD, PHD | Guangdong Provincial People's Hospital | Study Director |
| Hongmei Chen, MD | Guangdong Provincial People's Hospital | Study Director |
| Haoming Tian, MD | West China Hospital | Study Director |
| Hong Li, MD | Sir Run Run Shaw Hospital | Study Director |
| Fenping Zheng, MD | Sir Run Run Shaw Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Beijing Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15677775 | Background | Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care. 2005 Feb;28(2):254-9. doi: 10.2337/diacare.28.2.254. | |
| 25952634 | Result | Zhou J, Zheng F, Guo X, Yang H, Zhang M, Tian H, Guo L, Li Q, Mo Y, Jia W. Glargine insulin/gliclazide MR combination therapy is more effective than premixed insulin monotherapy in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. Diabetes Metab Res Rev. 2015 Oct;31(7):725-33. doi: 10.1002/dmrr.2661. Epub 2015 Jun 16. |
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|
|
| Biosynthetic Human Insulin Injection | Drug | Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months |
|
|
| 3 months |
| Study Director |
| Qiang Li, MD | The Second Affiliated Hospital of Harbin Medical University | Study Director |
| Xiaohui Guo, MD, PHD | Peking University First Hospital | Study Director |
| Ying Gao, MD, PHD | Peking University First Hospital | Study Director |
| Muxun Zhang, MD | Tongji Hospital | Study Director |
| Lixin Guo, MD, PHD | Beijing Hospital | Study Director |
| Yan Ren, MD, PHD | West China Hospital | Study Director |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
| Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200233 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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