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Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.It is urgent to explore more effective and safety treatments which can also protect islet cells function.How to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.
Patients were divided into 3 groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPP4 group | Experimental | DPP4 inhibitor,1 pill qd |
|
| insulin group | Experimental | insulin,glargine or detemir,0.2U/Kg,qd |
|
| SU group | Placebo Comparator | SU,Glimepiride,1-2mg qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP4 | Drug | sitagliptin phosphate 100mg qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose,glycosylated hemoglobin(GHbA1c) | mmol/L,% | From date of randomization until the date of first documented progression, assessed up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| weight loss | kilograms | From date of randomization until the date of first documented progression, assessed up to 3 months |
| Lipid changes | mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Sui, Doctor | Contact | 0086-18991989230 | suijing1029@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Sui, Doctor | First Affiliated Hospital of Xi'an Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33574913 | Derived | He M, Deng M, Wang J, Fan P, Wang Y, Zhao X, He Y, Shi B, Sui J. Efficacy and tolerability of sitagliptin and metformin compared with insulin as an initial therapy for newly diagnosed diabetic patients with severe hyperglycaemia. Exp Ther Med. 2021 Mar;21(3):217. doi: 10.3892/etm.2021.9649. Epub 2021 Jan 15. |
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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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D007328 | Insulin |
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Insulin | Drug | Insulin Glargine or detemir 0.2U/kg qd |
|
|
| SU | Drug | Glimepiride 1-2mg qd |
|
|
| From date of randomization until the date of first documented progression, assessed up to 3 months |
| Incidence of hypoglycemia | times | From date of randomization until the date of first documented progression, assessed up to 3 months |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D011384 | Proinsulin |
| 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 |
| D049528 | Insulin, Long-Acting |