TOND: Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
Patients were divided into 3 groups:
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DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;
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insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;
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Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DPP4 group DPP4 inhibitor,1 pill qd |
Drug: DPP4
sitagliptin phosphate 100mg qd
Other Names:
|
| Experimental: insulin group insulin,glargine or detemir，0.2U/Kg,qd |
Drug: Insulin
Insulin Glargine or detemir 0.2U/kg qd
Other Names:
|
| Placebo Comparator: SU group SU,Glimepiride，1-2mg qd |
Drug: SU
Glimepiride 1-2mg qd
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Fasting blood glucose,glycosylated hemoglobin(GHbA1c) [From date of randomization until the date of first documented progression, assessed up to 3 months]
mmol/L,%
Secondary Outcome Measures
- weight loss [From date of randomization until the date of first documented progression, assessed up to 3 months]
kilograms
- Lipid changes [From date of randomization until the date of first documented progression, assessed up to 3 months]
mmol/L
- Incidence of hypoglycemia [From date of randomization until the date of first documented progression, assessed up to 3 months]
times
Eligibility Criteria
Criteria
Inclusion Criteria:
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newly onset
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type 2 diabetes
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BMI 18-30kg/m2
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FBS≧11.1mmol/L，GHbA1c≧9%
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urine ket ≦(1+)
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Normal liver and kidney function
Exclusion Criteria:
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type 1 diabetes
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renal or hepatic insufficiency
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Severe ketoacidosis
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Treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs
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Severe systemic disease
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History of pancreatitis or pancreatic surgery
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Pregnant and lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
- Principal Investigator: Jing Sui, Doctor, First Affiliated Hospital of Xi'an Jiao Tong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJTU1AF2016LSL-048