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

Type 2 Diabetes Mellitus Clinical Trial

— TOND  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03180281
• Other study ID #: XJTU1AF2016LSL-048
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: June 6, 2017
• Start date: July 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jing Sui, Doctor
• Phone: 0086-18991989230
• Email: suijing1029[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients were divided into 3 groups:

1. DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;

2. insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;

3. Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• DPP4
sitagliptin phosphate 100mg qd
• Insulin
Insulin Glargine or detemir 0.2U/kg qd
• SU
Glimepiride 1-2mg qd

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiao Tong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	weight loss	kilograms	From date of randomization until the date of first documented progression, assessed up to 3 months
Secondary	Lipid changes	mmol/L	From date of randomization until the date of first documented progression, assessed up to 3 months
Secondary	Incidence of hypoglycemia	times	From date of randomization until the date of first documented progression, assessed up to 3 months