Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients were divided into 3 groups: DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose; insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin; Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;

Official Title
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Exploring Effective and Safety Therapies Which Protect Islet β Cell on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: DPP4
* Drug: Insulin
* Drug: SU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly onset type 2 diabetes BMI 18-30kg/m2 FBS≧11.1mmol/L，GHbA1c≧9% urine ket ≦(1+) Normal liver and kidney function Exclusion Criteria: type 1 diabetes renal or hepatic insufficiency Severe ketoacidosis Treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs Severe systemic disease History of pancreatitis or pancreatic surgery Pregnant and lactating women

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: DPP4 group<br>DPP4 inhibitor,1 pill qd | Drug: DPP4<br>* sitagliptin phosphate 100mg qd<br>* Other names: sitagliptin phosphate;|
| Experimental: insulin group<br>insulin,glargine or detemir，0.2U/Kg,qd | Drug: Insulin<br>* Insulin Glargine or detemir 0.2U/kg qd<br>* Other names: Glargine or detemir;|
| Placebo Comparator: SU group<br>SU,Glimepiride，1-2mg qd | Drug: SU<br>* Glimepiride 1-2mg qd<br>* Other names: Glimepiride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |