drugset / Trial / NCT03180281

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

NCT03180281

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-07-01
Primary completion
2020-01-01
Completion
2020-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Glimepiride Small molecule 1 mg
Comparator Glimepiride Small molecule 2 mg
Subject Sitagliptin Small molecule 100 mg Oral
Subject insulin detemir Protein / enzyme biologic 0.2 iu/kg
Subject insulin glargine Protein / enzyme biologic 0.2 iu/kg